Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShaheed Mohtarma Benazir Bhutto Institue of Trauma

About this trial

This randomized controlled trial will compare the prophylactic effectiveness of low-dose intravenous ketamine and tramadol in preventing post-spinal anesthesia shivering in patients undergoing orthopedic surgery at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT), Karachi,

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* ASA I and II patients aged 18-60 years.

Both genders.

Patients undergoing orthopedic surgery under spinal anesthesia.

Disqualifiers

* Patient refusal.

ASA III and ASA IV.

Prolonged surgical procedures expected to be more than 90 minutes.

Patients who received blood transfusion or study drugs other than for the study purpose.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tramadol

    Drug

    Intravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

  • Ketamin

    Drug

    Intravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Tramadol GroupActive comparator 1 intervention
Group B: Ketamine GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of post-spinal anesthesia shivering

Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.

Time frame
immediately after spinal anesthesia until 90 minutes post-spinal anesthesia

Secondary outcomes

1

Severity of post-spinal anesthesia shivering

Severity of post-spinal anesthesia shivering will be assessed and recorded.

Time frame
immediately after spinal anesthesia until 90 minutes post-spinal anesthesia

Other outcomes

Sponsors and contacts

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