Dexamethasone Improves Postoperative Symptoms After Laparoscopic Cholecystectomy (dxt)

This study has been completed.
Sponsor:
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01030614
First received: December 10, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Postoperative Pain
Postoperative Fatigue
Drug: Dexamethasone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexamethasone Improves Postoperative Symptoms in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Randomised Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • postoperative nausea and vomiting after elective laparoscopic cholecystectomy [ Time Frame: At recovery room after laparoscopic cholecystectomy and after 6, 12 and 24 hours. Follow-up during 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain and postoperative fatigue [ Time Frame: At recovery room after laparoscopic cholecystectomy and after 6, 12 and 24 hours. Follow-up 30 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 210
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone group
One hundred five patients were randomized to receive intravenous dexamethasone (8 mg) before laparoscopic cholecystectomy
Drug: Dexamethasone
intravenous dexamethasone 8 mgr before laparoscopic cholecystectomy or intravenous placebo before laparoscopic cholecystectomy
Placebo Comparator: Placebo group
One hundred five patients were randomized to receive intravenous placebo before laparoscopic cholecystectomy
Drug: Dexamethasone
intravenous dexamethasone 8 mgr before laparoscopic cholecystectomy or intravenous placebo before laparoscopic cholecystectomy
Drug: placebo
One hundred five patients were randomized to receive intravenous placebo before laparoscopic cholecystectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Adult patients (ASA I and II) with symptomatic cholelithiasis.

Exclusion Criteria:Patients of American Society of Anesthesiologists (ASA) classes III and IV were excluded. Further exclusion criteria were age more than 80 years; pregnancy; treatment with steroids; severe diabetes mellitus (HbA1c > 8%); use of opioids, sedatives or any kind of analgesics less than one week before LC; a history of alcohol or drug abuse; preoperative diagnosis of acute cholecystitis, acute pancreatitis, choledocolithiasis, gallbladder carcinoma and/or conversion of the LC to an open procedure.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030614

Locations
Mexico
Department of Surgery and Department od Anesthesiology. Specialties Hospital. Westerm Medical Center, Mexican Institute of Social Security.
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Alejandro Gonzalez-Ojeda, M.D., Ph.D., Full-time Surgical Researcher, Specialties Hospital. Mexican Insitute of Social Security
ClinicalTrials.gov Identifier: NCT01030614     History of Changes
Other Study ID Numbers: Dxt-2009-01
Study First Received: December 10, 2009
Last Updated: December 10, 2009
Health Authority: Mexico: Ministry of Health

Keywords provided by Instituto Mexicano del Seguro Social:
Laparoscopic cholecystectomy,postoperative symptoms

Additional relevant MeSH terms:
Fatigue
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms, Digestive
Nausea
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014