Abdominoplasty Under Spinal Anesthesia

January 17, 2019 updated by: Ayman Anis Metry, Ain Shams University

A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.

100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.

Study Type

Interventional

Enrollment (Actual)

200

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
        • ain shams 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 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients between 18-55 years
  • ASA I and II

Exclusion Criteria:

  • BMI more than 35 years
  • Contraindications for regional anesthesia

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Spinal anesthesia
Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.
Drug: Propofol 10 Mg/mL Intravenous Emulsion
when spinal anesthesia is not satisfactory intervention drugs are used
Other Names:
  • ketamine
NO_INTERVENTION: General anesthesia
General anesthesia for abdominoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain sensation: Visual analogue scale
Time Frame: pain assessment during the operation and every 4 hours for 12 hours
Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt
pain assessment during the operation and every 4 hours for 12 hours
Patients satisfaction: Satisfaction score changes
Time Frame: Intraoperative assessment every 30 minutes till end of surgery.
Satisfaction score with maximum score is fully satisfied and least is completely disagree
Intraoperative assessment every 30 minutes till end of surgery.

Collaborators and Investigators

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

Sponsor

Ain Shams 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 30, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (ACTUAL)

January 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASUH1011/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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