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Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery

ConditionsPost-spinal HypotensionOrthopedic SurgerySpinal Aneshtesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Ketamine GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
From spinal injection to end of surgery

Secondary outcomes

1

Incidence of Hallucinations

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

Time frame
From spinal injection to end of surgery
2

Incidence of Bradycardia

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.

Time frame
From spinal injection to end of surgery
3

Incidence of Nausea and Vomiting

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.

Time frame
From spinal injection to end of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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