Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

NCT06995690 | Recruiting

• 1 other identifier: FMASU MS 70/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-spinal Hypotension; Orthopedic Surgery; Spinal Aneshtesia

Keywords

Ketamine; Sub-anesthetic dose; Hypotension prevention; Neuraxial anesthesia; Hemodynamic stability; regional anesthesia; ASA I-II; Double-blind randomized trial; Blood pressure monitoring; Ephedrine use

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Spinal Hypotension

  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.

  From spinal injection to end of surgery

Secondary Outcomes (3)

• Incidence of Hallucinations

  From spinal injection to end of surgery

• Incidence of Bradycardia

  From spinal injection to end of surgery

• Incidence of Nausea and Vomiting

  From spinal injection to end of surgery

Study Arms (2)

Ketamine Group

EXPERIMENTAL

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: Ketamine

Control Group

PLACEBO COMPARATOR

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.

Drug: Normal Saline

Interventions

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.

Ketamine Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Ketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Reem H El Kabarity, M.D

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+201277719693; am.ga.ab.ab.mo@gmail.com

Mohammed S Shorbagy, M.D

CONTACT

+201069961005

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (Participant, Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)