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Sedation During 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: NCT03133780
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Seham Mohamed Moeen Ibrahim, Assiut University

Tracking Information
First Submitted Date  ICMJE April 26, 2017
First Posted Date  ICMJE April 28, 2017
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE July 14, 2018
Actual Primary Completion Date March 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score [ Time Frame: 90 min after the tested drug adminisred ]
assessed by modified observer's assessment of alertness/sedation score
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
Sedation assessed by modified observer's assessment of alertness/sedation score [ Time Frame: 90 min after spinal anesthesia ]
assessed by modified observer's assessment of alertness/sedation score
Change History
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 Sedation During Spinal Anesthesia
Official Title  ICMJE A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial
Brief Summary Patients during spinal anesthesia should be sedated.
Detailed Description Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Sedation During Spinal Anesthesia
Intervention  ICMJE
  • Drug: Ketamine
    Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
    Other Name: Ketalar
  • Drug: Midazolam
    Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
    Other Name: dormicum
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
    Intervention: Drug: Ketamine
  • Active Comparator: Midazolam
    Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
    Intervention: Drug: Midazolam
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: December 24, 2019)
80
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2017)
100
Actual Study Completion Date  ICMJE March 7, 2020
Actual Primary Completion Date March 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male patients aged from 18 to 40 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.

Exclusion Criteria:

  • Age: younger than 18 or older than 40.
  • Psychatric or neurological disorders.
  • Cardiovascular disorders.
  • Coagulation disorders.
  • Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT03133780
Other Study ID Numbers  ICMJE 42017
Has Data Monitoring Committee Not Provided
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 Not Provided
Current Responsible Party Seham Mohamed Moeen Ibrahim, Assiut University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assiut University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seham M Moeen, MD Assiut Univerisity
PRS Account Assiut University
Verification Date April 2021

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