Abdominoplasty Under Spinal Anesthesia

Spinal Anesthesia Suitability for Abdominoplasty Clinical Trial

Official title:

A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810547
• Other study ID #: ASUH1011/17
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All patients between 18-55 years

• ASA I and II

Exclusion Criteria:

• BMI more than 35 years

• Contraindications for regional anesthesia

Related Conditions & MeSH terms

• Spinal Anesthesia Suitability for Abdominoplasty

Intervention

Drug:
• Propofol 10 Mg/mL Intravenous Emulsion
when spinal anesthesia is not satisfactory intervention drugs are used

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain sensation: Visual analogue scale	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
Primary	Patients satisfaction: Satisfaction score changes	Satisfaction score with maximum score is fully satisfied and least is completely disagree	Intraoperative assessment every 30 minutes till end of surgery.