Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Caesarean Delivery.

Not Applicable

Completed

• Conditions: Hemodynamic Instability
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT05865080
• Lead Sponsor: Azhar University

Brief Summary

Hypotension is the most frequent side effect of intrathecal anesthesia, with a found incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial anesthesia. This study aimed to determine the multiple advantages of intravenous minimal dose ketamine for intrathecal anesthesia in patients undergoing cesarean delivery

Detailed Description

126 female patients undergoing cesarean deliveries, ASA-(II and III) and 21-40 ys old selected from an attendee of outpatient clinics of the Anesthesia Department. Two groups of patients were random to group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-04-18
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-18
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	Placebo	group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.
group K	Ketamine	group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution,

Primary Outcome Measures

Name	Time	Method
Hemodynamics	Up to 24 hours after operation	Primary outcomes: Hemodynamic parameters (MAP and HR). Secondary outcomes; 1. Incidence of intraoperative shivering.; 2. The postoperative pain was assessed by VAS score.; 3. Sedation score in between groups.; 4. Fetus evaluated by Apgar score.; 5. Postoperative side effects as nausea, vomiting, nystagmus, diplopia, and hallucinations.

Trial Locations

Locations (1)

Faculty of medicine -Al-Azhar university; 🇪🇬 Cairo, Egypt