Pain After Laparoscopic Cholecystectomy

NCT00983918 | Completed Results DMC

• 1 other identifier: H-24815
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane. PURPOSE To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain Measured on Verbal Scale of 0-10

  Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.

  24 hours

Study Arms (4)

Desflurane

ACTIVE COMPARATOR

General Anesthesia with Desflurane

Drug: Desflurane

Sevoflurane

ACTIVE COMPARATOR

General Anesthesia with Sevoflurane

Drug: Sevoflurane

Isoflurane

ACTIVE COMPARATOR

General Anesthesia with Isoflurane

Drug: Isoflurane

Propofol

ACTIVE COMPARATOR

General Anesthesia with Propofol

Drug: Propofol

Interventions

Desflurane DRUG

Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane

Desflurane

Sevoflurane DRUG

Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane

Sevoflurane

Isoflurane DRUG

Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane

Isoflurane

Propofol DRUG

Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion

Propofol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient ages 18-64
• American Society of Anesthesiology Physical Status I, II or III
• Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

You may not qualify if:

• Open cholecystectomy - excluded due to increased levels of pain in open procedures
• Scheduled for ambulatory surgery
• Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
• Allergy to any of the study medications or anesthetic agents
• Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
• Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
• Patient or surgeon refusal

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Desflurane; Sevoflurane; Isoflurane; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Jaime Ortiz, MD
• Organization: Baylor College of Medicine

jaimeo@bcm.edu

713-873-2860

Study Officials

• Jaime Ortiz, MD

  Baylor College of Medicine, Dept. of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 1, 2019
• Results First Posted: March 11, 2014

Record last verified: 2019-01

Locations

US (1)