Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis

J. Kleif; A. Kirkegaard; J. Vilandt; I. Gögenur

doi:10.1002/bjs.10418

Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis

J. Kleif^*, A. Kirkegaard, J. Vilandt, I. Gögenur

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

16 Citationer (Scopus)

Abstract

Background: Few studies have investigated the effects of preoperative dexamethasone in acute surgical patients. This study examined the effects of 8 mg dexamethasone administered intravenously 30 min before surgery for suspected acute appendicitis. Methods: A multicentre, parallel-group, double-blind, placebo-controlled study was conducted at two university hospitals in Denmark. Adults undergoing laparoscopic surgery for suspected appendicitis were eligible for inclusion. Participants, healthcare staff and investigators were blinded until all data analysis had been done. The primary outcome was the incidence of postoperative nausea and vomiting (PONV) during the first postoperative day. Secondary outcomes were pain, fatigue, sleep, opioid consumption, use of antiemetics, quality of recovery and duration of convalescence. Analysis was done according to the intention-to-treat principle. Results: A total of 120 patients were enrolled; 57 patients in the dexamethasone group and 59 in the placebo group were eligible for primary analysis. In the dexamethasone group, 47 (95 per cent c.i. 35 to 60) per cent of patients experienced PONV compared with 63 (50 to 74) per cent) in the placebo group. The absolute risk reduction in PONV was 15 (–3 to 33) per cent in favour of the dexamethasone group (P = 0·098). Patients in the dexamethasone group had less pain at rest (difference in score on visual analogue scale (VAS) 9 (95 per cent c.i. 1 to 17) mm; P = 0·024), were less fatigued (difference in VAS score 7 (0 to 14) mm; P = 0·038), used fewer opioids (absolute risk reduction 17 (2 to 33) per cent; P = 0·033) and had better quality of recovery (difference in QoR-15 score 13 (4 to 22); P = 0·006) during the first postoperative day. There was no difference in postoperative complications (P = 0·595). Conclusion: Preoperative dexamethasone did not reduce PONV by the target level of 50 per cent. Registration number: NCT02415335 (http://www.clinicaltrials.gov).

Originalsprog	Engelsk
Tidsskrift	British Journal of Surgery
Vol/bind	104
Udgave nummer	4
Sider (fra-til)	384-392
Antal sider	9
ISSN	0007-1323
DOI	https://doi.org/10.1002/bjs.10418
Status	Udgivet - mar. 2017

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10.1002/bjs.10418

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@article{a18ecffc0d7f475fb2ffd9b51d60eacc,

title = "Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis",

abstract = "Background: Few studies have investigated the effects of preoperative dexamethasone in acute surgical patients. This study examined the effects of 8 mg dexamethasone administered intravenously 30 min before surgery for suspected acute appendicitis. Methods: A multicentre, parallel-group, double-blind, placebo-controlled study was conducted at two university hospitals in Denmark. Adults undergoing laparoscopic surgery for suspected appendicitis were eligible for inclusion. Participants, healthcare staff and investigators were blinded until all data analysis had been done. The primary outcome was the incidence of postoperative nausea and vomiting (PONV) during the first postoperative day. Secondary outcomes were pain, fatigue, sleep, opioid consumption, use of antiemetics, quality of recovery and duration of convalescence. Analysis was done according to the intention-to-treat principle. Results: A total of 120 patients were enrolled; 57 patients in the dexamethasone group and 59 in the placebo group were eligible for primary analysis. In the dexamethasone group, 47 (95 per cent c.i. 35 to 60) per cent of patients experienced PONV compared with 63 (50 to 74) per cent) in the placebo group. The absolute risk reduction in PONV was 15 (–3 to 33) per cent in favour of the dexamethasone group (P = 0·098). Patients in the dexamethasone group had less pain at rest (difference in score on visual analogue scale (VAS) 9 (95 per cent c.i. 1 to 17) mm; P = 0·024), were less fatigued (difference in VAS score 7 (0 to 14) mm; P = 0·038), used fewer opioids (absolute risk reduction 17 (2 to 33) per cent; P = 0·033) and had better quality of recovery (difference in QoR-15 score 13 (4 to 22); P = 0·006) during the first postoperative day. There was no difference in postoperative complications (P = 0·595). Conclusion: Preoperative dexamethasone did not reduce PONV by the target level of 50 per cent. Registration number: NCT02415335 (http://www.clinicaltrials.gov).",

author = "J. Kleif and A. Kirkegaard and J. Vilandt and I. G{\"o}genur",

year = "2017",

month = mar,

doi = "10.1002/bjs.10418",

language = "English",

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TY - JOUR

T1 - Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis

AU - Kleif, J.

AU - Kirkegaard, A.

AU - Vilandt, J.

AU - Gögenur, I.

PY - 2017/3

Y1 - 2017/3

N2 - Background: Few studies have investigated the effects of preoperative dexamethasone in acute surgical patients. This study examined the effects of 8 mg dexamethasone administered intravenously 30 min before surgery for suspected acute appendicitis. Methods: A multicentre, parallel-group, double-blind, placebo-controlled study was conducted at two university hospitals in Denmark. Adults undergoing laparoscopic surgery for suspected appendicitis were eligible for inclusion. Participants, healthcare staff and investigators were blinded until all data analysis had been done. The primary outcome was the incidence of postoperative nausea and vomiting (PONV) during the first postoperative day. Secondary outcomes were pain, fatigue, sleep, opioid consumption, use of antiemetics, quality of recovery and duration of convalescence. Analysis was done according to the intention-to-treat principle. Results: A total of 120 patients were enrolled; 57 patients in the dexamethasone group and 59 in the placebo group were eligible for primary analysis. In the dexamethasone group, 47 (95 per cent c.i. 35 to 60) per cent of patients experienced PONV compared with 63 (50 to 74) per cent) in the placebo group. The absolute risk reduction in PONV was 15 (–3 to 33) per cent in favour of the dexamethasone group (P = 0·098). Patients in the dexamethasone group had less pain at rest (difference in score on visual analogue scale (VAS) 9 (95 per cent c.i. 1 to 17) mm; P = 0·024), were less fatigued (difference in VAS score 7 (0 to 14) mm; P = 0·038), used fewer opioids (absolute risk reduction 17 (2 to 33) per cent; P = 0·033) and had better quality of recovery (difference in QoR-15 score 13 (4 to 22); P = 0·006) during the first postoperative day. There was no difference in postoperative complications (P = 0·595). Conclusion: Preoperative dexamethasone did not reduce PONV by the target level of 50 per cent. Registration number: NCT02415335 (http://www.clinicaltrials.gov).

AB - Background: Few studies have investigated the effects of preoperative dexamethasone in acute surgical patients. This study examined the effects of 8 mg dexamethasone administered intravenously 30 min before surgery for suspected acute appendicitis. Methods: A multicentre, parallel-group, double-blind, placebo-controlled study was conducted at two university hospitals in Denmark. Adults undergoing laparoscopic surgery for suspected appendicitis were eligible for inclusion. Participants, healthcare staff and investigators were blinded until all data analysis had been done. The primary outcome was the incidence of postoperative nausea and vomiting (PONV) during the first postoperative day. Secondary outcomes were pain, fatigue, sleep, opioid consumption, use of antiemetics, quality of recovery and duration of convalescence. Analysis was done according to the intention-to-treat principle. Results: A total of 120 patients were enrolled; 57 patients in the dexamethasone group and 59 in the placebo group were eligible for primary analysis. In the dexamethasone group, 47 (95 per cent c.i. 35 to 60) per cent of patients experienced PONV compared with 63 (50 to 74) per cent) in the placebo group. The absolute risk reduction in PONV was 15 (–3 to 33) per cent in favour of the dexamethasone group (P = 0·098). Patients in the dexamethasone group had less pain at rest (difference in score on visual analogue scale (VAS) 9 (95 per cent c.i. 1 to 17) mm; P = 0·024), were less fatigued (difference in VAS score 7 (0 to 14) mm; P = 0·038), used fewer opioids (absolute risk reduction 17 (2 to 33) per cent; P = 0·033) and had better quality of recovery (difference in QoR-15 score 13 (4 to 22); P = 0·006) during the first postoperative day. There was no difference in postoperative complications (P = 0·595). Conclusion: Preoperative dexamethasone did not reduce PONV by the target level of 50 per cent. Registration number: NCT02415335 (http://www.clinicaltrials.gov).

U2 - 10.1002/bjs.10418

DO - 10.1002/bjs.10418

M3 - Journal article

C2 - 28072446

AN - SCOPUS:85009480759

SN - 0007-1323

VL - 104

SP - 384

EP - 392

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 4

ER -

Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis

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