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Effect of combination of ketamine and midazolam in different doses in prevention of shivering in patient undergoing spinal anaesthesia

TO COMPARE THE Efficacy OF TWO DIFFERENT COMBINATIONS OF LOW DOSES OF KETAMINE AND MIDAZOLAM IN PREVENTION OF SHIVERING AFTER SUBARACHNOID BLOCK - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112037
Enrollment
120
Registered
2026-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Inj ketamine 0.25mg/kg and Inj midazolam 0.02 mg/kg diluted in 0.9% normal saline up to 5ml,: The study drugs will be immediately administered (within 5. minutes) after administering sp

Sponsors

Smt Bhikiben Kanjibhai Shah Medical institute and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to sign informed consent. 2. Male or female patients between 18 to 65 years of age. 3. Patients belonging to American Society of Anaesthesiologists (ASA) physical status l and I. 4. Patients posted for elective lower limb surgeries under subarachnoid block.

Exclusion criteria

Exclusion criteria: 1. Emergency surgeries. 2. Patient not willing to sign the consent form. 3. Patients with extensive fractures, massive wounds, burns, those who received massive blood transfusions. 4. Patients contraindicated to undergo spinal anaesthesia. 5. Patient with history of hypothyroidism, hyperthyroidism, significant cardiovascular disease, pregnant patients. 6. Patients with history of psychiatric disorders, history of alcohol or substance abuse 7. Patients receiving vasodilators or medications that influence thermoregulation 8. Patients with multiple drug allergies, patients with an initial body temperature of more than 38 deg C or less than 36 degrees C. 9. Patients with history of PONV and motion sickness.

Design outcomes

Primary

MeasureTime frame
This is a prospective and comparative study which will help us to compare the efficacy of two different combinations of low doses of ketamine and midazolam in prevention of shivering afer subarachnoid block for elective lower limb surgeries and will enable us to estimate the approximate drug dosage level which is most beneficial in prevention of shivering.Timepoint: preop 5mins 10mins 15mins 30mins 45mins 60mins 90 mins—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactDr Dinesh K Chauhan

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre

dr.dinesh77@gmail.com9099014672

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026