Dexamethasone Improves Postoperative Symptoms After Laparoscopic Cholecystectomy

NCT01030614 | Completed Phase 3

• 1 other identifier: Dxt-2009-01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy (LC). However, its effects on other surgical outcomes such as pain and fatigue have been unclear. We evaluated the efficacy of preoperative dexamethasone in ameliorating postoperative symptoms after LC. Methods: Prospective, double-blind, placebo-controlled study, 210 patients scheduled for elective LC were analyzed after randomization to intravenous dexamethasone (8 mg) or to a placebo. All patients underwent standardized procedures for general anesthesia and surgery. Episodes of PONV and pain and fatigue scores were recorded on a visual analogue scale. Analgesic and antiemetic requirements were also recorded.

Conditions

Postoperative Nausea and Vomiting; Postoperative Pain; Postoperative Fatigue

Keywords

Laparoscopic cholecystectomy,postoperative symptoms

Outcome Measures

Primary Outcomes (1)

• postoperative nausea and vomiting after elective laparoscopic cholecystectomy

  At recovery room after laparoscopic cholecystectomy and after 6, 12 and 24 hours. Follow-up during 30 days after surgery

Secondary Outcomes (1)

• Pain and postoperative fatigue

  At recovery room after laparoscopic cholecystectomy and after 6, 12 and 24 hours. Follow-up 30 days after surgery

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

One hundred five patients were randomized to receive intravenous dexamethasone (8 mg) before laparoscopic cholecystectomy

Drug: Dexamethasone

Placebo group

PLACEBO COMPARATOR

One hundred five patients were randomized to receive intravenous placebo before laparoscopic cholecystectomy

Drug: Dexamethasone; Drug: placebo

Interventions

Dexamethasone DRUG

intravenous dexamethasone 8 mgr before laparoscopic cholecystectomy or intravenous placebo before laparoscopic cholecystectomy

Dexamethasone group; Placebo group

placebo DRUG

One hundred five patients were randomized to receive intravenous placebo before laparoscopic cholecystectomy

Placebo group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Department of Surgery and Department od Anesthesiology. Specialties Hospital. Westerm Medical Center, Mexican Institute of Social Security.

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Alejandro Gonzalez-Ojeda, M.D., Ph.D.

  Full-time Surgical Researcher and Professor of Surgery. Surgical Research Unit. Specialties Hospital. Mexican Institute of Social Security. Guadalajara, Jal. Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: January 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 11, 2009

Record last verified: 2009-01

Locations

ME (1)