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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05865080
• Other study ID #: 12345
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

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
Normal saline

Locations

Country	Name	City	State
Egypt	Faculty of medicine -Al-Azhar university	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Azhar University	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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