Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

NCT ID: NCT06995690

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-11-01

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.

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.

Conditions

Post-spinal Hypotension; Orthopedic Surgery; Spinal Aneshtesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ketamine Group

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: 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.

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reem H El Kabarity, M.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

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

Role: CONTACT

am.ga.ab.ab.mo@gmail.com

+201277719693

Mohammed S Shorbagy, M.D

Role: CONTACT

+201069961005

Other Identifiers

FMASU MS 70/2025

Identifier Type: -

Identifier Source: org_study_id