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Effect of administration of cold and warm bupivacaine with fentanyl on the incidence of shievering.

Effect of administration of cold and warm 0.5% hyperbaric Bupivacaine with fentanyl on the incidence of shivering: a prospective randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024084
Enrollment
100
Registered
2020-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: D303- Benign neoplasm of bladder Health Condition 2: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 3: C679- Malignant neoplasm of bladder, unspecified Health Condition 4: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 5: C55- Malignant neoplasm of uterus, partunspecified Health Condition 6: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Administration of warm bupivacaine with fentanyl in spinal anaesthesia: Group BT will receive intrathecal 10 mg(2ml) 0.5% hyperbaric bupivacaine with 25 mcg(0.5ml) fentanyl warmed at 37

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Age group of 50 to 75 years. •Undergoing elective urological, gynaecological, lower abdominal or lower extremity procedures under spinal anaesthesia. •Surgical time up to 2 hours and anaesthesia time not exceeding 2.5 hours.

Exclusion criteria

Exclusion criteria: • Contraindications to SA such as pre-existing coagulopathy, local sepsis at site of insertion, hypovolemia, spinal dysraphism, previous history of spinal instrumentation or surgery, spinal deformity. • Unwillingness for SA. • Unwilling to participate in this trial. • Surgical time > 2 hours and anaesthetic time > 2.5 hours. • Cases converted to General anaesthesia during the surgical procedure. • Height 180 cm. • Weight 100kg.

Design outcomes

Primary

MeasureTime frame
To observe the incidence of intra and postoperative shivering after spinal anaesthesia in two groups of patientsTimepoint: From injection of spinal drug to 2 hours after surgery—

Secondary

MeasureTime frame
To also observe and compare the difference if any, between the two groups in terms of Intra and Post-operative nausea and vomiting Level of anaesthesia and analgesia Duration of anaesthesia and analgesia Degree of hypotension and heart rate changes Timepoint: From injection of spinal drug to 24 hour after surgery—

Countries

India

Contacts

Public ContactAjay Singh

PGIMER Chandigarh

ajay.ydv2509@gmail.com9999276845

Outcome results

None listed

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