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Completed

NCT Number: NCT04721054

Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Epidural Anesthesia General Anesthesia Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Hospital

Rawalpindi, Punjab Province, 68000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other names: Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomy

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

Other names: general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomy

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Armed Forces Hospital, Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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