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Sedation During Spinal Anesthesia

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03133780
Enrollment
80
Registered
2017-04-28
Start date
2018-07-14
Completion date
2020-03-07
Last updated
2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation During Spinal Anesthesia

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.

Interventions

DRUGKetamine

Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

DRUGMidazolam

Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score90 minutes after spinal anesthesiaassessed by modified observer's assessment of alertness/sedation score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026