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NCT Number: NCT06995690

Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing 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 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 90 mmHg and/or mean arterial pressure less than 60 mmHg).
  • Patients aged below 18 years.
  • Duration of operation below 1 hour or above 3 hours.

Treatment and study plan

ketamine

Drug

Patients receive crystalloid preloading of 15ml/kg (Ringer's lactate) +the sub-anesthetic dose of ketamine of 0.5 mg/kg IV added to the first bottle of ringer for blinding over 20 min before the spinal injection.

normal saline

Drug

Patients receive a crystalloid preloading of 15 ml/kg (Ringer's lactate)+ 0.5 mg/kg IV of Normal Saline added to the first bottle of ringer for blinding, over 20 min before the spinal injection.

Primary outcomes

  1. Incidence of Post-Spinal Hypotension

    Time frame: From spinal injection to end of surgery

    Hypotension is defined as a mean arterial pressure (MAP) less than 20% below baseline. MAP will be calculated using the formula: MAP = DBP + (SBP - DBP)/3.

    Hypotension will be treated with boluses of IV Ephedrine (3mg) and repeated if needed. The total dose of ephedrine required to correct hypotension and raise the MAP to the baseline will be recorded.

Secondary outcomes

  1. Incidence of Hallucinations

    Time frame: From spinal injection to end of surgery

    Visual or auditory disturbances post ketamine administration. Midazolam (2 mg IV) will be given pre-injection to mitigate risk.

  2. Incidence of Bradycardia

    Time frame: From spinal injection to end of surgery

    Bradycardia is defined as Heart Rate less than 50 beats per minute. Bradycardia will be treated with IV atropine (0.04 mg/kg) and repeated if needed.

  3. Incidence of Nausea and Vomiting

    Time frame: From spinal injection to end of surgery

    Nausea is defined as an unpleasant subjective urge to vomit and Vomiting is defined as propulsive abdominal muscular spasms associated with the expulsion of gastric contents.

    Nausea and vomiting will be treated with 3 mg IV Granisetron.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira G Abdelmoniem Abdalla, M.B.B.Ch.

CONTACT

[email protected]

+201277719693

Mohammed S Shorbagy, M.D

CONTACT

+201069961005

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Sub-anesthetic Dose of Ketamine in the Prevention of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
Jun 18, 2025

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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