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

Al-Azhar University126 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

126

Conditions

Hemodynamic Instability

Interventions

KetamineDRUG

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

PlaceboDRUG

Normal saline

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of medicine -Al-Azhar university

Cairo, Egypt

Outcomes

Primary Outcomes

Hemodynamics

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.

Time frame: Up to 24 hours after operation

Data from ClinicalTrials.gov

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