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Effect of Intravenous Dexmedetomidine on Patient Discomfort in Laparoscopic Cholecystectomy Under Spinal Anesthesia.

NCT04115449 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-02

No results posted yet for this study

Summary

Laparoscopic cholecystectomy (LC) has been routinely performed under general anesthesia despite the several disadvantages of general anesthesia compared to regional anesthesia.

There are multiple reports that have been published regarding the feasibility of spinal anesthesia for LC associated with many problems such as referred shoulder pain secondary to intra-abdominal pneumoperitoneum; patient anxiety, pain, and discomfort; and inadequate sedation.The aim of our study is to prospectively observe the feasibility of using intravenous dexmedetomidine to abolish patient discomfort and shoulder pain, thus making the patient more comfortable without causing excessive sedation and respiratory depression.

Conditions

  • Shoulder Pain

Interventions

DRUG

Dexmedetomidine

Injection dexmedetomidine 1 mcg /kg will be infused over a period of ten minutes

DRUG

normal saline

Normal Saline as a placebo will be infused over a period of ten minutes

Sponsors & Collaborators

  • Theodor Bilharz Research Institute

    lead OTHER

Principal Investigators

  • Moshira S Mohamed, MD · Theodor Bilharz Research Institute

  • Hend F Hassan, MD · Theodor Bilharz Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2021-05-31
Completion
2021-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115449 on ClinicalTrials.gov