Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy

January 21, 2021 updated by: arshad khushdil, Armed Forces Hospital, Pakistan

Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided into two groups, T and G, randomly. In Group T all patients underwent laparoscopic cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1% lignocaine plain whereas in group G all patients underwent surgery under general anesthesia. Intra-operative heart rate, mean arterial pressure (MAP) and post operative opioid consumption in first 24hrs were recorded as primary outcomes whereas presence or absence of respiratory complication and duration of hospital stay as secondary outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 68000
        • Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients having ASA statusI-III
  2. age more than 18 years,
  3. both genders
  4. planned to undergo laparoscopic cholecystectomy

Exclusion Criteria:

  1. Patients who did not give consent,
  2. Allergic to local anesthetic
  3. Hemodynamically unstable,
  4. Pregnant, full stomach patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group receiving thoracic epidural anesthesia
Drug: Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine)
patients in epidural anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
Other Names:
  • Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomy
ACTIVE_COMPARATOR: group receiving thoracic general anesthesia
Drug: general anesthesia effect on heart rate in Laparoscopic Cholecystectomy
patients in general anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
Other Names:
  • general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in heart rate during surgery in immediate 24 hours-heart rate.
Time Frame: changes in heart rate at 24 hours of surgery.
the efficacy of thoracic epidural anesthesia was compared with general anesthesia for laproscopic cholecystectomy in the immediate post operative period in terms of intra operative heart rate.
changes in heart rate at 24 hours of surgery.
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in mean arterial blood pressure during surgery in immediate 24 hours-mean arterial blood pressure.
Time Frame: changes in mean arterial pressure at 24 hours of surgery
efficacy of thoracic epidural anesthesia was compared with general anesthesia for laproscopic cholecystectomy in the immediate post operative period in terms of mean arterial blood pressure intra operatively and in immediate post operative period
changes in mean arterial pressure at 24 hours of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

January 2, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104589

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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