Abdominoplasty Under Spinal Anesthesia

NCT ID: NCT03810547

Last Updated: 2019-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Anesthesia Suitability for Abdominoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Spinal anesthesia

Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.

Group Type ACTIVE_COMPARATOR

Propofol 10 Mg/mL Intravenous Emulsion

Intervention Type DRUG

when spinal anesthesia is not satisfactory intervention drugs are used

General anesthesia

General anesthesia for abdominoplasty

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Propofol 10 Mg/mL Intravenous Emulsion

when spinal anesthesia is not satisfactory intervention drugs are used

Intervention Type DRUG

Other Intervention Names

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ketamine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* BMI more than 35 years
* Contraindications for regional anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Anis Metry

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASUH1011/17

Identifier Type: -

Identifier Source: org_study_id

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