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Abdominoplasty Under Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03810547
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Anis Metry, Ain Shams University

Brief Summary:
100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Suitability for Abdominoplasty Drug: Propofol 10 Mg/mL Intravenous Emulsion Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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 Name: ketamine

No Intervention: General anesthesia
General anesthesia for abdominoplasty



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI more than 35 years
  • Contraindications for regional anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810547


Locations
Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

Responsible Party: Ayman Anis Metry, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03810547     History of Changes
Other Study ID Numbers: ASUH1011/17
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayman Anis Metry, Ain Shams University:
Abdominoplasty
spinal anesthesia
general anesthesia
postoperative pain

Additional relevant MeSH terms:
Anesthetics
Propofol
Ketamine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action