Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721054
• Other study ID #: 104589
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: January 2021
• Source: Armed Forces Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Anesthesia
• General Anesthesia

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Military Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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