Sedation During Spinal Anesthesia

NCT ID: NCT03133780

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-14
• Study Completion Date: 2020-03-07

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.

Conditions

Sedation During Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

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

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

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

Midazolam

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Midazolam

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

Intervention Type: DRUG

Other Intervention Names

Ketalar; dormicum

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Seham Mohamed Moeen Ibrahim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seham M Moeen, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut Univerisity

Locations

Faculty of Medicine Assuit University

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

42017

Identifier Type: -

Identifier Source: org_study_id