Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy

NCT ID: NCT04721054

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epidural Anesthesia General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one group to be studied for effects of epidural anesthesia and other group for effects of general anesthesia
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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group receiving thoracic epidural anesthesia

Group Type ACTIVE_COMPARATOR

Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine)

Intervention Type DRUG

patients in epidural anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure

group receiving thoracic general anesthesia

Group Type ACTIVE_COMPARATOR

general anesthesia effect on heart rate in Laparoscopic Cholecystectomy

Intervention Type DRUG

patients in general anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomy general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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arshad khushdil

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Military Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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104589

Identifier Type: -

Identifier Source: org_study_id

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