In the study, people are randomly given either Nalbuphine or Dexmedetomidine with Bupivacaine, and the researchers will compare which one is more effective at stopping shivering after the procedure.

Intrathecal Nalbuphine versus Dexmedetomidine as adjuvants with Bupivacaine in prevention of Post Spinal Shivering - A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081101

Enrollment

Registered

2025-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: S720- Fracture of head and neck of femur Health Condition 2: S822- Fracture of shaft of tibia Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 4: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 5: S723- Fracture of shaft of femur Health Condition 6: O- Medical and Surgical Health Condition 7: O- Medical and Surgical

Interventions

Intervention1: Group A: patients will receive intrathecal Nalbuphine: Group A: patients will receive 3ml of 0.5% hyperbaric Bupivacaine with 0.1ml of 1mg Nalbuphine and assessed for post spinal shiver

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group 18 to 60 years 2. ASA I and ASA II 3. Patient planned for elective lower abdominal and lower limb surgeries under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Contraindication for spinal anaesthesia 3. BMI more than 30

Design outcomes

Primary

Measure	Time frame
To assess the incidence and severity of post spinal shivering with intrathecal Nalbuphine and Dexmedetomidine as an adjuvant with Bupivacaine in spinal anaesthesia. Timepoint: 7 hours intraoperatively and postoperatively	—

Secondary

Measure	Time frame
To assess: Hemodynamic parameters (Heart Rate, Mean Arterial Blood Pressure, Oxygen Saturation, Respiratory Rate and Temperature) Sedation (Ramsay Sedation Score) Adverse events if any (Nausea, vomiting and drug allergies) Timepoint: 7hours intraoperatively and postoperatively	—

Countries

India

Contacts

Public ContactDr Nivetha Manikandan

Aarupadai veedu medical College and hospital

ezhilrajan96@gmail.com9843030074

Outcome results

None listed

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