Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery

October 13, 2024 updated by: Amr Samir Wahdan, Cairo University
The combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. CSEGA has several known advantages including appropriate postoperative analgesia, shows some benefit in the intraoperative blood loss control causing a decreased need for blood transfusion, rapid regain of the gastrointestinal actions and decreases the incidence of postoperative respiratory complications. Unfortunately, the drawbacks of using neuro-axial anesthesia in combination to general anesthesia will be not thoroughly introduced in many researches, thus, remain unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
      • Cairo, Egypt, 11562
        • Cairo University

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

  1. Inclusion criteria:

    • Patients aged from 18 to50 years.
    • ASA I-II.
    • undergoing elective liposuction surgery
    • BMI from 25 to 40 kg/m2

  2. Exclusion criteria:

    • Patient refusal
    • ASA III-IV.
    • Patients aged less than 18 or more than 50.
    • Body mass index >40.
    • Any contraindications to neuro-axial block such as coagulopathy or spine deformity
    • Chronic opioid consumption,
    • History of parenteral or oral analgesic intake within the last 48hours.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CSEGA group
Will be received combined spinal-epidural-general anesthesia.
Device: spinal-epidural device
received combined spinal-epidural-general anesthesia.
No Intervention: GA group
will be received general anesthesia only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: 24 hours
postoperative morphine consumption
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative patient satisfaction
Time Frame: 24 hours
1 = very unsatisfactory; 2 = unsatisfactory; 3 = indifferent; 4 = satisfactory; and 5 = very satisfactory.
24 hours
Intraoperative surgeon satisfaction.
Time Frame: 6 hours
using 1-4 scales (1, bad; 2, moderate; 3, good; 4, excellent;
6 hours
Incidence of complications
Time Frame: 24 hours
such as hypotension, bradycardia, nausea and vomiting, postoperative shivering,
24 hours
Blood loss
Time Frame: 6 hours
intraoperative Blood loss
6 hours

Collaborators and Investigators

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

Sponsor

Cairo 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 (Actual)

January 11, 2022

Primary Completion (Actual)

August 13, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • N-54-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

still working

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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