Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy

NCT04721054 | Completed

• 1 other identifier: 104589
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidural Anesthesia; General Anesthesia

Keywords

headache; blood pressure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Study Arms (2)

group receiving thoracic epidural anesthesia

ACTIVE COMPARATOR

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

group receiving thoracic general anesthesia

ACTIVE COMPARATOR

Drug: general anesthesia effect on heart rate in Laparoscopic Cholecystectomy

Interventions

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

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

Also known as: Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomy

group receiving thoracic epidural anesthesia

general anesthesia effect on heart rate in Laparoscopic Cholecystectomy DRUG

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

Also known as: general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomy

group receiving thoracic general anesthesia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients having ASA statusI-III
• age more than 18 years,
• both genders
• planned to undergo laparoscopic cholecystectomy

You may not qualify if:

• Patients who did not give consent,
• Allergic to local anesthetic
• Hemodynamically unstable,
• Pregnant, full stomach patients

Sponsors & Collaborators

• Armed Forces Hospital, Pakistan: lead

Study Sites (1)

Military Hospital

Rawalpindi, Punjab Province, 68000, Pakistan

Location

MeSH Terms

Conditions

Headache

Interventions

Cholecystectomy, Laparoscopic; Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: one group to be studied for effects of epidural anesthesia and other group for effects of general anesthesia

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 22, 2021
• Study Start: October 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

PA (1)