It is study to know which drug have better effect from iv nalbuphine versus iv ketamine for the prevention of shivering after spinal anaesthesia

A prospective randomized study to compare the efficacy of intravenous nalbuphine versus intravenous low dose ketamine for prevention of post spinal anaesthesia shivering - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092678

Enrollment

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Intravenous Inj. Nalbuphine 0.1mg/kg: Intravenous Inj. Nalbuphine 0.1mg/kg diluted till 10 ml in sterile NS will be given 15-20 mins after spinal anaesthesia Control Intervention1: Inrt

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients voluntarilly willing to sign informed consent. 2.Male or female patients between 18 to 65 years of age. 3.Patients with Body Mass Index less than 30 kg per m2 4.Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II. 5.Patients posted for elective surgeries under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1.Patients unwilling to participate in the study. 2.Patients with American society of Anesthesiiologist (ASA) physical status III, IV, V 3.Patients with Body Mass Index more than 30 kg per m2. 4.Patients with alcohol or other drug addiction. 5.Patients in which spinal anaesthesia coverted to general anaesthesia. 6.Patient with preexisting hoarseness or sore throat or upper respiratory tract infection. 7.Patients with cardiovascular diseases, Neurological diseases, Spinal Deformities and patient on opioid medications. 8.Patients with history of allergy to opioids. 9.Pregnancy & lactating women.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of drugs for incidence and prevention of post spinal shivering using shivering score in patient undergoing spinal anaesthesiaTimepoint: At Baseline At time of Induction At time of giving drug at 10 mins after giving drug At 30 mins after giving drug At 60 mins after giving drug At 90 mins after giving drug	—

Secondary

Measure	Time frame
To compare the peri operative hemodynamic responseTimepoint: baseline at time of induction at time of drug administration 5 mins after drug 10 mins after drug 15 mins after drug 30 mins after drug 60 mins after drug 90 mins after drug also post in operative period at 0 hour at 1 hour at 2 hour at 3 hour at 6 hour at 12 hour at 24 hour	—

Countries

India

Contacts

Public ContactDr Jatin Patel

Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre

dr_jatinpatel@yahoo.co.in9879368363

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026