A randomised controlled trial of propofol vs. thiopentone and desflurane for fatigue after laparoscopic cholecystectomy
2017; Wiley; Volume: 72; Issue: 7 Linguagem: Inglês
10.1111/anae.13909
ISSN1365-2044
AutoresTorkjell Nøstdahl, Olav Magnus S. Fredheim, Tomm Bernklev, T. S. Doksrod, Randi Marie Mohus, Johan Ræder,
Tópico(s)Anesthesia and Pain Management
ResumoAnaesthesiaVolume 72, Issue 7 p. 864-869 Original ArticleFree Access A randomised controlled trial of propofol vs. thiopentone and desflurane for fatigue after laparoscopic cholecystectomy T. Nostdahl, Corresponding Author T. Nostdahl Senior Consultant [email protected] Department of Anaesthesiology, Telemark Hospital, Skien, Norway Correspondence to: T. Nostdahl Email: [email protected]Search for more papers by this authorO. M. Fredheim, O. M. Fredheim Professor, Senior Consultant Department of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway Centre of Palliative Medicine, Surgical Division, Akershus University Hospital, Lørenskog, Norway National Competence Centre for Complex Symptom Disorders, Department of Pain and Complex Disorders, Trondheim, NorwaySearch for more papers by this authorT. Bernklev, T. Bernklev Research Director, Professor Research and Development, Vestfold Hospital Trust, Tønsberg, Norway Institute of Clinical Medicine, Medical Faculty, University of Oslo, Oslo, NorwaySearch for more papers by this authorT. S. Doksrod, T. S. Doksrod Senior Consultant Department of Anaesthesiology, Telemark Hospital, Skien, NorwaySearch for more papers by this authorR. M. Mohus, R. M. Mohus Senior Consultant Department of Anaesthesiology, St. Olav University Hospital, Trondheim, NorwaySearch for more papers by this authorJ. Raeder, J. Raeder Professor, Senior Consultant Institute of Clinical Medicine, Medical Faculty, University of Oslo, Oslo, Norway Department of Anaesthesiology, Oslo University Hospital, Oslo, NorwaySearch for more papers by this author T. Nostdahl, Corresponding Author T. Nostdahl Senior Consultant [email protected] Department of Anaesthesiology, Telemark Hospital, Skien, Norway Correspondence to: T. Nostdahl Email: [email protected]Search for more papers by this authorO. M. Fredheim, O. M. Fredheim Professor, Senior Consultant Department of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway Centre of Palliative Medicine, Surgical Division, Akershus University Hospital, Lørenskog, Norway National Competence Centre for Complex Symptom Disorders, Department of Pain and Complex Disorders, Trondheim, NorwaySearch for more papers by this authorT. Bernklev, T. Bernklev Research Director, Professor Research and Development, Vestfold Hospital Trust, Tønsberg, Norway Institute of Clinical Medicine, Medical Faculty, University of Oslo, Oslo, NorwaySearch for more papers by this authorT. S. Doksrod, T. S. Doksrod Senior Consultant Department of Anaesthesiology, Telemark Hospital, Skien, NorwaySearch for more papers by this authorR. M. Mohus, R. M. Mohus Senior Consultant Department of Anaesthesiology, St. Olav University Hospital, Trondheim, NorwaySearch for more papers by this authorJ. Raeder, J. Raeder Professor, Senior Consultant Institute of Clinical Medicine, Medical Faculty, University of Oslo, Oslo, Norway Department of Anaesthesiology, Oslo University Hospital, Oslo, NorwaySearch for more papers by this author First published: 26 April 2017 https://doi.org/10.1111/anae.13909Citations: 3 You can respond to this article at http://www.anaesthesiacorrespondence.com AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Summary Fatigue may delay functional recovery after day surgery and may be more common after propofol anaesthesia. We randomly allocated 123 participants scheduled for ambulatory laparoscopic cholecystectomy to induction and maintenance of general anaesthesia with propofol or thiopentone and desflurane. Postoperative fatigue was unaffected by the allocated anaesthetic. The combined mean (SD) Identity-Consequences Fatigue Scale of 34.3 (15.1) before surgery increased in the first postoperative week: to 60.4 (21.1) on day 1, p < 0.001; to 51.1 (17.2) on day 2, p < 0.001; and to 37.5 (16.3) on day 6, p = 0.028. The mean (SD) fatigue reduced at one postoperative month to 22.4 (12.6), 35% less than the combined pre-operative level, p < 0.001. Rates of nausea, vomiting and rescue antie-mesis during the first week after propofol, compared with thiopentone and desflurane, were: 23/63 vs. 32/60, p = 0.27; 8/63 vs. 9/60, p = 0.71; and 12/63 vs. 28/60, p = 0.001, respectively. There were no differences in postoperative pain. In conclusion, fatigue after scheduled laparoscopic cholecystectomy was unaffected by anaesthesia with propofol vs. thiopentone and desflurane. Introduction Fatigue is a subjective experience, often defined as a persistent tiredness or weakness, being physical, mental or both. It is common in the general population 1, 2 and more prevalent in a wide range of diseases and after surgery. Postoperative fatigue may prevent mobilisation and delay discharge after day surgery, although it is infrequently reported in studies after otherwise uncomplicated surgery 3. The incidence, severity and duration of postoperative fatigue may be affected by the operation performed 3-6. The aetiology of postoperative fatigue is poorly understood and appears to involve biological, psychological and social factors 3, 6, 7. Drugs, such as opioids, may cause fatigue 8, which is distinct from the residual sedative effects of anaesthetic and analgesic drugs 9, 10. Propofol and desflurane are among the most widely used anaesthetic agents in modern day surgery. They are rapidly cleared from the body and might not be expected to cause cognitive dysfunction or fatigue. However, one study reported that fatigue one week after laparoscopic cholecystectomy was more common after propofol than desflurane 11. Our aim was to investigate whether fatigue up to one month after laparoscopic cholecystectomy was different in participants anaesthetised with propofol compared with thiopentone and desflurane, using a measure specifically designed for detailed assessment of postoperative fatigue 12. Our secondary aim was to study postoperative rates of nausea, vomiting, pain and sleep. Methods The Committee for Medical Research Ethics of South-Eastern Norway approved this trial. Participants provided written consent after receiving oral and written information. We included patients aged 18–70 years, ASA physical status 1–2, who were fluent in Norwegian and who were scheduled for ambulatory laparoscopic cholecystectomy at Telemark Hospital, September 2010 to June 2013. Exclusion criteria were: pregnancy or breastfeeding; patients with illness characterised by fatigue, such as adrenal disease, fibromyalgia and severe chronic pain; and patients taking long-term opioids. We used the Apfel score to estimate risk of postoperative nausea or vomiting 13. We recorded baseline characteristics and participants completed a questionnaire on admission to hospital. We allocated participants to treatment groups using a computer-generated sequence, contained in consecutively numbered opaque envelopes, which we opened a few minutes before induction of anaesthesia. The allocation sequence was generated, protected and kept separate from investigators. Participants were not told whether anaesthesia would be maintained with propofol or desflurane. We induced anaesthesia in one group with intravenous propofol 1.5–2.5 mg.kg−1 and with intravenous thiopentone 4–6 mg.kg−1 in the other group. Tracheal intubation was facilitated with intravenous vecuronium 0.1 mg.kg−1 followed by additional intra-operative doses if required. The lungs were ventilated with air supplemented to an oxygen concentration of about 50%. We maintained anaesthesia with intravenous propofol titrated to an effect-site concentration 2.7–3.3 μg.ml−1 (Schnider model) 14 or with desflurane titrated to an end-tidal minimum alveolar concentration 0.7–0.8, respectively. We infused intravenous remifentanil during surgery to an estimated effect-site concentration 4–10 ng.ml−1 (Minto model) 15, 16, adjusted to maintain a systolic blood pressure 85–110 mmHg. After 15–30 min, we recorded a representative response entropy value (Datex-Ohmeda) for each participant. During surgery, we injected intravenously: dexamethasone 0.15 mg.kg−1 (up to 16 mg); ondansetron 4 mg; paracetamol 1 g; and ketorolac 30 mg. The surgeon injected 20 ml ropivacaine 2.0 mg.ml−1 inside the peritoneal cavity and another 20 ml subcutaneously at the incisions. We antagonised neuromuscular blockade with intravenous neostigmine 2.5 mg, combined with glycopyrronium 0.5 mg, when surgery was completed. We injected intravenous fentanyl in aliquots of 50 μg before tracheal extubation if spontaneous ventilation exceeded 15 breaths.min−1, titrated to a rate of 10–14 min−1. We treated postoperative nausea or vomiting with intravenous metoclopramide 20 mg followed by haloperidol 1.0 mg (up to 3.0 mg) as necessary. We treated initial postoperative pain with intravenous fentanyl in aliquots of 25–50 μg. We gave oral paracetamol 1 g six-hourly, supplemented by oral diclofenac 50 mg every 8 h, which were continued at home. We gave participants questionnaires to complete on postoperative days 1, 3, 6 and 30. A specialist nurse telephoned participants the day after surgery and reminded them to complete the first questionnaire. Participants received reminders by text on days 3, 6 and 30. Participants returned the first three questionnaires in a pre-stamped envelope and the final questionnaire in a separate envelope 3–4 weeks later. We measured fatigue with the 10-item shortened version (10-SF) of the 31-item Identity-Consequences Fatigue Scale (range 0–100). The 10-SF retains more than 98% of the information in the full scale 17. In addition, the Fatigue Questionnaire (FQ) 18 was applied for benchmarking with data from the general population in Norway 1. A nurse recorded nausea, vomiting and antie-metic administration while participants were in hospital. On postoperative days 1, 3, 6 and 30, participants recorded nausea, average pain and most severe pain on 11-point numeric rating scales (NRS). We categorised nausea as absent or mild (0–2) or not (3–10). Participants recorded analgesic consumption and sleep on a 5-point verbal rating scale. At each time point, participants were asked to measure symptoms within the previous 24 h for postoperative day 1 and within the previous 48 h for baseline and postoperative days 3, 6 and 30. The primary outcome was fatigue during the first postoperative week. It is not known what difference in 10-SF score equates to a clinically significant difference; 10%–20% changes in quality-of-life scores are considered important 19, 20. We calculated that we would need to analyse results from 53 participants in each group to have a 90% probability of detecting a difference of at least 16 points at a significance threshold of 0.05, assuming a standard deviation of 25. We intended to recruit 128 participants on the assumption that we would lose data from 15% to 20%. We analysed results per protocol, supplemented by intention-to-treat analyses. We imputed missing fatigue data with the mean score if 50% or more of the questions for that factor were completed. We analysed categorical data with the chi-squared test. We used independent t-tests to analyse fatigue scores separately at each time point. When the analyses showed no difference between the treatment groups at any of the observation points, the combined data for both groups were compared with baseline data using a paired data t-test in order to study the course of fatigue during the first postoperative month. We used SPSS versions 21 and 23 (IBM SPSS, New York, NY, USA) to analyse data. Results We analysed data for 123 participants, 13 of whom did not return the questionnaires after one week, and an additional 11 participants did not return the final questionnaire (Fig. 1). Participants who did not return the questionnaires were younger than those who did, mean (SD) age 39.3 (12.4) years vs. 48.0 (12.3) years, p = 0.002. There were only 50/17,500 missing fatigue data items in returned questionnaires. Participants were anaesthetised by authors TN (106), RM (13) or TD (4). Peri-operative participant characteristics are listed in Table 1. The combined mean (SD) pre-operative score measured by the Fatigue Questionnaire was similar to that reported in the general Norwegian population 1: 12.4 (3.4) vs. 12.2 (4.0) p = 0.59. Figure 1Open in figure viewerPowerPoint CONSORT flow chart of trial recruitment of patients scheduled for ambulatory laparoscopic cholecystectomy, allocated to anaesthetic induction and maintenance with propofol or thiopentone and desflurane. Table 1. Demographic and peri-operative characteristics for 123 participantsrandomly allocated to one of two different anaesthetic regimes who had scheduled ambulatory laparoscopic cholecystectomy. Values are mean (SD) or number Propofol Desflurane p value n = 63 n = 60 Age; years 46.6 (12.7) 46.0 (12.9) Sex; male/female 13/50 12/48 BMI; kg.m−2 28.0 (4.8) 28.0 (4.3) ASA physical status; 1/2/3 16/45/2 27/33/0 Apfel index; 1/2/3/4 6/28/19/10 4/19/20/17 0.27 Propofol; mg 747 (241) – – Thiopentone; mg – 418 (69) – Desflurane end-tidal; % – 4.5 (0.4) – Remifentanil; μg.kg−1 14.4 (5.0) 13.7 (5.2) 0.46 Intra-operative fentanyl; μg 99 (51) 107 (49) 0.41 Intra-operative variables Maximum SBP; mmHg 120 (19) 113 (14) 0.015 Minimum SBP; mmHg 81 (13) 80 (9) 0.79 Maximum DBP; mmHg 76 (12) 68 (12) < 0.001 Minimum DBP; mmHg 48 (8) 45 (7) 0.08 Maximum HR; min−1 75 (14) 69 (11) 0.007 Minimum HR; min−1 54 (9) 47 (8) < 0.001 Entropy at steady state 36 (6) 40 (7) < 0.001 Gallbladder perforation 15 11 0.46 Surgery; min 55 (21) 52 (21) 0.38 Anaesthesia; min 81 (22) 77 (25) 0.35 Time to extubationa; min 9.5 (4.5) 7.2 (3.4) 0.002 Postoperative fentanyl; μg 104 (93) 113 (75) 0.67 Postoperative stay; h 3.9 (1.6) 4.4 (1.4) 0.048 a From the end of surgery. BMI, body mass index; DBP, diastolic blood pressure; SBP, systolic blood pressure; HR, heart rate. Fatigue was unaffected by the type of anaesthetic (Fig. 2). The combined mean (SD) pre-operative 10-SF score of 34.3 (15.1) increased in the first postoperative week: to 60.4 (21.1) on day 1, p < 0.001; to 51.1 (17.2) on day 2, p < 0.001; and to 37.5 (16.3) on day 6, p = 0.028. The mean (SD) fatigue reduced at one postoperative month to 22.4 (12.6), 35% less than the combined pre-operative level, p < 0.001. Figure 2Open in figure viewerPowerPoint Fatigue scores (10-SF) after scheduled laparoscopic cholecystectomy in 63 participants anaesthetised with propofol () and 60 participants anaesthetised with thiopentone and desflurane (). Values are mean (SD). The anaesthetic agent did not affect postoperative fatigue. Participants anaesthetised with propofol reported reduced sleep on the first postoperative night, whereas participants anaesthetised with thiopentone and desflurane reported unchanged sleep (Fig. 3). Rates of nausea, vomiting and rescue antie-mesis during the first week after propofol, compared with thiopentone and desflurane, were: 23/63 vs. 32/60, p = 0.27; 8/63 vs. 9/60, p = 0.71 and 12/63 vs. 28/60, p = 0.001, respectively. The mean (SD) consumption of oral paracetamol and diclofenac during the first week after propofol, compared with thiopentone and desflurane, were: 8.37 (5.82) g vs. 10.12 (6.36) g, p = 0.135; and 338 (229) mg vs. 431 (252) mg, p = 0.043, respectively. No participant consumed opioids at home. The mean (SD) severe and average pain scores during the first week after propofol compared with thiopentone and desflurane were: 3.44 (1.77) vs. 3.56 (1.77), p = 0.72; and 2.61 (1.46) vs. 2.69 (1.63), p = 0.78, respectively. Figure 3Open in figure viewerPowerPoint Amount of sleep, 'Last night I've slept…', reported after scheduled laparoscopic cholecystectomy by 63 participants anaesthetised with propofol () and 60 participants anaesthetised with thiopentone and desflurane (). Values are mean (SD). There was no difference between the groups. Compared with pre-operative sleep, participants anaesthetised with propofol slept less on the first postoperative night, p < 0.001. Discussion Fatigue increased in the first week after scheduled laparoscopic cholecystectomy. Fatigue was reduced compared with pre-operative values at one postoperative month. The magnitude of these changes was similar after general anaesthesia with propofol or thiopentone and desflurane. Major surgery, with extensive tissue trauma and inflammation, is associated with greater initial fatigue than minor surgery 5, 21. Techniques that limit trauma and inflammation might also cause less fatigue 22, 23. Yet, some operations that entail extensive tissue damage, such as hip or knee arthroplasty, have not been associated with much fatigue 3, 6, 24. We think that participants might have adjusted their reference point by the time they reported reduced fatigue at one postoperative month, below the norm for the Norwegian population 1. Reference point adjustment is more common in chronic illness, with residual disability, than in illness without residual symptoms 25. Similar postoperative reductions in fatigue have been described after other operations 5, 7, 23. It is unclear whether disturbed sleep is independently associated with postoperative fatigue and if it is, whether it is causative 26. A previous study reported that propofol caused more fatigue than desflurane 1 week after cholecystectomy 11. Chance or differences in the study designs and populations might account for our different results. Participants were more nauseated after maintenance with desflurane than propofol, which is in keeping with other trials 27, 28. However, we also gave thiopentone to participants anaesthetised with desflurane, which causes more postoperative nausea and vomiting than propofol 29, 30. Perforation of the gallbladder occurred in 21% of operations and was not associated with postoperative fatigue, nausea or pain (data not presented). We gave all participants a single dose of dexamethasone, which reduces postoperative pain, nausea, vomiting and fatigue 31-33. This might have reduced the power of our study to detect an effect of anaesthetic agent on fatigue, although we were still able to detect an effect on rates of antiemetic given in hospital. Anaesthetists and other staff might have biased their performance as they knew which anaesthetic participants had received. Outcome assessors were blinded. We are confident that our results are representative of our cohort as 89% and 80% complete questionnaires were returned after one week and one month, respectively. We used the 10-SF to measure fatigue, which is validated for surgical populations, thereby addressing concerns that unevaluated methods were used for postoperative fatigue 5, 22. In conclusion, we found no difference in fatigue between propofol and thiopentone with desflurane up to one month after surgery. Increased fatigue was a consistent feature of recovery during the first week after laparoscopic cholecystectomy. Acknowledgements We thank the staff at our Day Surgery Unit for providing invaluable practical and logistical help during the data collection period. We also thank Telemark Hospital Trust for funding this project. Telemark Hospital Trust, Department of Research and Development has been the sole funding source, providing a partial buy-out from consultant practice for Torkjell Nostdahl. 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