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OpenTrials
Completed

NCT Number: NCT05865080

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

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Key information

Conditions

Hemodynamic Instability

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine -Al-Azhar university

Cairo, 11765, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Drug

Normal saline

Primary outcomes

  1. Hemodynamics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2023
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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