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

Sponsor

Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT05865080

Collaborator

Al-Azhar University (Other)

126

Enrollment

Location

Arms

7.1

Actual Duration (Months)

17.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Drug: Ketamine Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Hemodynamics [Up to 24 hours after operation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criter

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

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine -Al-Azhar university	Cairo		Egypt	11765

Sponsors and Collaborators

Azhar University
Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mohamed, assisstant professor of anesthesia, Azhar University

ClinicalTrials.gov Identifier:

NCT05865080

Other Study ID Numbers:

12345

First Posted:

May 18, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by mohamed, assisstant professor of anesthesia, Azhar University

spinal anesthesia

obstetric anesthesia

Additional relevant MeSH terms:

Ketamine

Study Results

No Results Posted as of May 22, 2023