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OpenTrials
Completed

NCT Number: NCT03133780

Sedation During Spinal Anesthesia

Patients during spinal anesthesia should be sedated.

Completed

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Key information

Conditions

Sedation During Spinal Anesthesia

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine Assuit University

Asyut, Asyut Governorate, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

ketamine

Drug

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

midazolam

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2017
Registry last updated
Feb 21, 2024

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.