Sedation During Spinal Anesthesia

Sedation During Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133780
• Other study ID #: 42017
• Status: Completed
• Phase: Phase 2
• Start date: July 14, 2018
• Est. completion date: March 7, 2020

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients during spinal anesthesia should be sedated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 7, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Sedation During Spinal Anesthesia

Intervention

Drug:
• Ketamine
Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
• Midazolam
Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assuit University	Assiut	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score	assessed by modified observer's assessment of alertness/sedation score	90 minutes after spinal anesthesia