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Clinical Trial
. 2003 Nov;238(5):651-60.
doi: 10.1097/01.sla.0000094390.82352.cb.

Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial

Affiliations
Clinical Trial

Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial

Thue Bisgaard et al. Ann Surg. 2003 Nov.

Abstract

Objective: To determine the effects of preoperative dexamethasone on surgical outcome after laparoscopic cholecystectomy (LC).

Summary background data: Pain and fatigue are dominating symptoms after LC and may prolong convalescence.

Methods: In a double-blind, placebo-controlled study, 88 patients were randomized to intravenous dexamethasone (8 mg) or placebo 90 minutes before LC. Patients received a similar standardized anesthetic, surgical, and multimodal analgesic treatment. All patients were recommended 2 days postoperative duration of convalescence. The primary endpoints were fatigue and pain. Preoperatively and at several times during the first 24 postoperative hours, we measured C-reactive protein (CRP) and pulmonary function, pain scores, nausea, and number of vomiting episodes were registered. Analgesic and antiemetic requirements were recorded. Also, on a daily basis, patients reported scores of fatigue and pain before and during the first postoperative week and the dates for resumption of work and recreational activities.

Results: Eight patients were excluded from the study, leaving 40 patients in each study group for analysis. There were no apparent side effects of the study drug. Dexamethasone significantly reduced postoperative levels of CRP (P = 0.01), fatigue (P = 0.01), overall pain, and incisional pain during the first 24 postoperative hours (P < 0.05) and total requirements of opioids (P < 0.05). In addition, cumulated overall and visceral pain scores during the first postoperative week were significantly reduced (P < 0.05). Dexamethasone also reduced nausea and vomiting on the day of operation (P < 0.05). Resumption of recreational activities was significantly faster in the dexamethasone group versus placebo group (median 1 day versus 2 days) (P < 0.05).

Conclusion: Preoperative dexamethasone (8 mg) reduced pain, fatigue, nausea and vomiting, and duration of convalescence in patients undergoing noncomplicated LC, when compared with placebo, and is recommended for routine use.

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Figures

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FIGURE 1. Changes in (a) fatigue scores and (b) overall pain scores in patients receiving (○) dexamethasone (n = 40) or (▪) placebo (n = 40) before laparoscopic cholecystectomy. Patients who received dexamethasone were significantly less fatigued on postoperative day 1 (*P < 0.05) and throughout the study period (P = 0.01) and suffered significantly less overall pain on postoperative day 1 (P < 0.01). Cumulated fatigue and pain scores were significantly lower in the dexamethasone group (see text for details). Values are median; VAS, visual analogue scale.
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FIGURE 2. Changes in scores of (a) overall pain, (b) incisional pain, and (c) visceral pain in patients receiving (○) dexamethasone (n = 40) or (▪) placebo (n = 40) during the first 24 hours after laparoscopic cholecystectomy. Total added pain scores for overall pain and incisional pain during mobilization were significantly lower in the dexamethasone group (see text for details). Shoulder pain scores are not shown since median scores throughout the study period were zero in both study groups with no significant intergroup difference (see text). Values are median; VAS = visual analogue scale. *P < 0.05.
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FIGURE 3. Changes in (a) forced vital capacity (FVC), (b) peak flow, (c) forced expiratory volume in 1 second, and (d) oxygen saturation (SpO2) during the first 24 hours after laparoscopic cholecystectomy in patients randomized to preoperative (○) dexamethasone (n = 40) or (▪) placebo (n = 40). There were no significant intergroup differences except for SpO2 intergroup changes during the study period (P < 0.01).
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FIGURE 4. Changes in (a) serum C-reactive protein (CRP) levels and (b) body temperature in patients receiving (○) dexamethasone (n = 40) or (▪) placebo (n = 40) before laparoscopic cholecystectomy. The increase in CRP was significantly higher in the dexamethasone group (P < 0.01). There were no intergroup differences in body temperature during the test period (P = 0.5). Values are median.

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