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Recruiting NCT06995690

Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

No phase Interventional Post-spinal Hypotension Orthopedic Surgery Spinal Aneshtesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine, Normal Saline.
Who it may be relevant to
Registry conditions: Post-spinal Hypotension, Orthopedic Surgery, Spinal Aneshtesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • Drug Ketamine
    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.
  • Drug Normal Saline
    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 outcome measures

  • Incidence of Post-Spinal Hypotension [Time frame: From spinal injection to end of surgery]
Secondary outcome measures (3)
  • Incidence of Hallucinations [Time frame: From spinal injection to end of surgery]
  • Incidence of Bradycardia [Time frame: From spinal injection to end of surgery]
  • Incidence of Nausea and Vomiting [Time frame: From spinal injection to end of surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Ain Shams University Hospitals — Cairo

Identifiers

NCT: NCT06995690 · FMASU MS 70/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗