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

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

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

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Drug: Placebo; Drug: Ketamine

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11765
    • Faculty of medicine -Al-Azhar university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criter

1. Female patients and full-term,
2. aged between (21 and 40) y. Old.
3. (ASA)-II or III, and undergoing a cesarean section.

Exclusion criteria:

1. Twins and preterm birth.
2. Hypertensive patients and preeclamptic patients.
3. Morbidly obese patients.
4. Spinal anesthesia contraindication as the patient refused, severe mitral or tricuspid stenosis and local sepsis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group K; 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,	Drug: Ketamine; 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution before spinal anesthesia
Placebo Comparator: group C; group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.	Drug: Placebo; Normal saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azhar University
• Collaborators: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: spinal anesthesia; obstetric anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No