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Pain After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00983918
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : March 11, 2014
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Desflurane Drug: Sevoflurane Drug: Isoflurane Drug: Propofol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Laparoscopic Cholecystectomy After Anesthesia With Isoflurane, Desflurane, Sevoflurane or Propofol
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Desflurane
General Anesthesia with Desflurane
 Drug: Desflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
Active Comparator: Sevoflurane
General Anesthesia with Sevoflurane
 Drug: Sevoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
Active Comparator: Isoflurane
General Anesthesia with Isoflurane
 Drug: Isoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
Active Comparator: Propofol
General Anesthesia with Propofol
 Drug: Propofol
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion


Outcome Measures
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Primary Outcome Measures :
  1. Pain Measured on Verbal Scale of 0-10 [ Time Frame: 24 hours ]
    Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
  2. Scheduled for ambulatory surgery
  3. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
  4. Allergy to any of the study medications or anesthetic agents
  5. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
  6. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
  7. Patient or surgeon refusal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983918


Locations
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United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Jaime Ortiz, MD Baylor College of Medicine, Dept. of Anesthesiology
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jaime Ortiz, Assistant Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00983918    
Other Study ID Numbers: H-24815
First Posted: September 24, 2009    Key Record Dates
Results First Posted: March 11, 2014
Last Update Posted: February 1, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Propofol
Sevoflurane
Desflurane
Isoflurane
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation