Spinal for Laparoscopic Cholecystectomy (Sp-Lap)

July 16, 2016 updated by: AlRefaey Kandeel, Mansoura University
In this study, the investigators will study spinal anesthesia for laparoscopic cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a primary variable, intraoperative complications, postoperative analgesic requirements, postoperative nausea and vomiting, patient hospital stay (secondary variables).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dkahleya
      • Mansoura, Dkahleya, Egypt
        • Recruiting
        • Mansoura University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

  • coagulopathy
  • Patient refusal
  • previous spine surgery
  • Obesity BMI more than 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General anesthesia group
General anesthesia group: Standard anesthetic technique will be applied.Anesthesia will be induced by propofol 1% (1-2 mg/kg), Fentanyl 1-2 mic/kg, and Atracurium 0.5 mg/kg then according to train of four response. Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..
Drug: General anesthesia
Induction by propofl 1.5-2 mg/kg, Fentanyl 1-2 mic/kg and atracrium 0.5 mg/kg Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..
Experimental: Spinal anesthesia group
While in sitting position; intrathecal injection using 25 G spinal needle using 3 mls of Bupivacaine 0.5% with 20 mic Fentanyl, at L 2-3 level the patient head will be lowered till sensory blockade of T6 obtained at least.
Drug: Bupivacaine with Fentanyl (Spinal Anesthesia)
Intrathecal injection of 15 mg Bupivacaine 0.5% at L 2-3 level mixed with 20 µ Fentanyl. Patients head will be lowered till sensory level of T 6 is abstained.
Other Names:
  • intrathecal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction (over a scale from 1 to 4)
Time Frame: 24 hours
24 hours
Postoperative analgesic consumption (mg morphine)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 8, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 16, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Refa32016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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