Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

Last updated: June 15, 2025
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedic Surgery

Circulation Disorders

Vascular Diseases

Treatment

Normal Saline

Ketamine

Clinical Study ID

NCT06995690
FMASU MS 70/2025
  • Ages > 18
  • All Genders

Study Summary

This randomized, double-blind, controlled clinical trial investigates the efficacy of a sub-anesthetic dose of ketamine (0.5 mg/kg IV) in preventing post-spinal hypotension in patients undergoing elective orthopedic surgeries under spinal anesthesia. The study compares ketamine with placebo (normal saline) in terms of blood pressure stability and incidence of hypotensive episodes following spinal anesthesia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients American Society of Anesthesiologists Physical Status (ASA) I to IIundergoing orthopedic surgeries under spinal anesthesia.

  • Both Sexes.

  • Patients aged equal to or above 18 years.

  • Body mass index <35 kg/m2

  • Duration of operation from 1 hour to 3 hours

Exclusion

Exclusion Criteria:

  • Patients' refusal of procedure or participation in the study.

  • Patients with contraindication to spinal anesthesia.

  • Patients with cardiovascular or pulmonary disease.

  • Patients with pre-procedural hypotension (systolic arterial pressure less than 90mmHg and/or mean arterial pressure less than 60 mmHg).

  • Patients aged below 18 years.

  • Duration of operation below 1 hour or above 3 hours.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Normal Saline
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
November 01, 2025

Study Description

Spinal anesthesia is commonly used for orthopedic procedures due to its effectiveness and favorable recovery profile. However, spinal-induced hypotension is a frequent complication resulting from sympathetic blockade, which can compromise organ perfusion and increase perioperative risk. This study aims to determine whether a single sub-anesthetic dose of intravenous ketamine administered before spinal anesthesia can reduce the incidence of hypotension.

Patients will be randomly allocated to either a ketamine group (receiving 0.5 mg/kg ketamine IV diluted in Ringer's lactate) or a control group (receiving volume-equivalent normal saline). Both interventions are administered over 20 minutes prior to the spinal injection to ensure blinding. All patients will undergo standard spinal anesthesia with 0.5% heavy bupivacaine plus fentanyl.

Primary outcome is the incidence of hypotension (defined as a mean arterial pressure drop >20% from baseline). Secondary outcomes include bradycardia, nausea, vomiting, hallucinations, and total dose of vasopressors required. The findings aim to support or refute the use of ketamine as a prophylactic strategy to stabilize hemodynamics during spinal anesthesia.

Connect with a study center

  • Ain Shams University Hospitals

    Cairo,
    Egypt

    Active - Recruiting

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