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Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

R

RESnTEC, Institute of Research

Status

Completed

Conditions

LAPAROSCOPIC CHOLECYSTECTOMY

Treatments

Drug: Bupivacaine injection
Drug: Dexmedetomidine injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06560892
DRQAZIANEESBVH

Details and patient eligibility

About

For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.

Enrollment

68 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of either gender
  • Aged between 20 and 70 years
  • ASA (American Society of Anesthesiologists Classification) physical status I and II
  • Undergoing Laparoscopic Cholecystectomy under general anesthesia

Exclusion criteria

  • Patients sensitive to local anesthetics
  • Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
  • Patients with uncontrolled diabetes (FBS≥110 mg/dl)
  • Uncontrolled blood pressure (SBP≥140 mmHg)
  • Ischemic heart disease (EF≤40%)
  • Pulmonary dysfunction (FEV≤70 percent of normal)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Bupivacaine group
Experimental group
Description:
Patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline
Treatment:
Drug: Bupivacaine injection
Bupivacaine + Dexmedetomidine group
Experimental group
Description:
Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml
Treatment:
Drug: Dexmedetomidine injection
Drug: Bupivacaine injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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