Clinical trial NCT06995690: Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery
Official title: Impact of Sub-anesthetic Dose of Ketamine in the Prevention of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Post-Spinal Hypotension
timeFrame: From spinal injection to end of surgery
Secondary outcomes:
measure: Incidence of Hallucinations
timeFrame: From spinal injection to end of surgery
measure: Incidence of Bradycardia
timeFrame: From spinal injection to end of surgery
measure: Incidence of Nausea and Vomiting
timeFrame: From spinal injection to end of surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Reem H El Kabarity, M.D
role: PRINCIPAL_INVESTIGATOR
References: