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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05865080

Enrollment

126

Registered

2023-05-18

Start date

2022-07-01

Completion date

2023-02-01

Last updated

2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Keywords

spinal anesthesia, obstetric anesthesia

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.

Interventions

DRUGKetamine

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

DRUGPlacebo

Normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026