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Abdominoplasty Under Spinal Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE January 30, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Change in Pain sensation: Visual analogue scale [ Time Frame: pain assessment during the operation and every 4 hours for 12 hours ]
    Visual analogue scale
  • Patients satisfaction: Satisfaction score changes [ Time Frame: Intraoperative assessment every 30 minutes till end of surgery. Maximum score is fully satisfied and least is completely disagree ]
    Satisfaction score
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abdominoplasty Under Spinal Anesthesia
Official Title  ICMJE A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Spinal Anesthesia Suitability for Abdominoplasty
Intervention  ICMJE Drug: Propofol 10 Mg/mL Intravenous Emulsion
when spinal anesthesia is not satisfactory intervention drugs are used
Other Name: ketamine
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Propofol 10 Mg/mL Intravenous Emulsion
  • No Intervention: General anesthesia
    General anesthesia for abdominoplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI more than 35 years
  • Contraindications for regional anesthesia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810547
Other Study ID Numbers  ICMJE ASUH1011/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayman Anis Metry, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP