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OpenTrials
Completed

NCT Number: NCT03810547

Abdominoplasty Under Spinal Anesthesia

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

Completed

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Key information

Conditions

Spinal Anesthesia Suitability for Abdominoplasty Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • BMI more than 35 years
  • Contraindications for regional anesthesia

Treatment and study plan

Propofol 10 Mg/mL Intravenous Emulsion

Drug

when spinal anesthesia is not satisfactory intervention drugs are used

Other names: ketamine

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2019
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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