Abdominoplasty Under Spinal Anesthesia

Not Applicable

Completed

• Conditions: Spinal Anesthesia Suitability for Abdominoplasty
• Interventions: Drug: Propofol 10 Mg/mL Intravenous Emulsion

• Registration Number: NCT03810547
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-30
• Primary Completion: 2018-04-30
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

• BMI more than 35 years
• Contraindications for regional anesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia	Propofol 10 Mg/mL Intravenous Emulsion	Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.

Primary Outcome Measures

Name	Time	Method
Change in Pain sensation: Visual analogue scale	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
Patients satisfaction: Satisfaction score changes	Intraoperative assessment every 30 minutes till end of surgery.	Satisfaction score with maximum score is fully satisfied and least is completely disagree

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt