Sedation During Spinal Anesthesia

February 20, 2024 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial

Patients during spinal anesthesia should be sedated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asyut
      • Assiut, Asyut, Egypt, 71516
        • Faculty of Medicine Assuit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male patients aged from 18 to 50 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 50.
  • Psychatric or neurological disorders.
  • Cardiovascular disorders.
  • Coagulation disorders.
  • Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • Ketalar
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
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 Names:
  • dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
Time Frame: 90 minutes after spinal anesthesia
assessed by modified observer's assessment of alertness/sedation score
90 minutes after spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Seham M Moeen, MD, Assiut Univerisity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2018

Primary Completion (Actual)

March 7, 2020

Study Completion (Actual)

March 7, 2020

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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