Dexamethasone Improves Postoperative Symptoms After Laparoscopic Cholecystectomy (dxt)
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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. |
- 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 ]
- 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 |
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| Mexico | |
| Department of Surgery and Department od Anesthesiology. Specialties Hospital. Westerm Medical Center, Mexican Institute of Social Security. | |
| Guadalajara, Jalisco, Mexico, 44340 | |
| 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 June 18, 2013