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Intravenous dexmedetomidine and paracetamol in bupivacaine spinal anesthesia

A comparison of effects of intravenous dexmedetomidine and paracetamol in bupivacaine spinal anesthesia in lower abdominal and pelvic surgeries.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018801
Enrollment
165
Registered
2019-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 Dexmedetomidine: Intravenous Dexmedetomidine given 15 minutes before giving spinal anaesthesia and thereby assessing the duration and quality of spinal block Intervention2:

Sponsors

Department of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) class I or II 2. Age: 18 to 70 years 3. Measuring 150-180 cm height, with body mass index (BMI) of 18-35 kg/m2 4. Patients undergoing elective lower abdominal and pelvic surgeries requiring spinal anaesthesia (maximum surgery duration-2hours)

Exclusion criteria

Exclusion criteria: 1. All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre-existing neurological deficits in lower extremities, unwillingness to give consent. 2. Sensory blockade inadequate for surgery. 3. Patients on alpha-2 adrenergic receptors antagonists, calcium channel blockers, or angiotensin-converting enzyme inhibitors. 4. Patients having cardiac rhythm abnormalities. 5. History of alcoholism, drug abuse, and psychiatric disorders. 6. History of allergy to any of the study drugs. 7. Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders. 8. Laparotomy, chronic abdominal pain undergoing treatment with opioid analgesic. 9. Pregnant patients. 10. Orthopaedic surgeries. 11. Surgeries extending more than 2 hours.

Design outcomes

Primary

MeasureTime frame
1. To compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries.Timepoint: Intra-operatively - 1. Time of T10 sensory block 2. Maximal sensory block achieved 3. Time of Bromage 3 motor block Post-operatively - 1. Time to sensory regression (2 dermatomes) 2. Time to motor regression (Bromage 1) 3. Time of first analgesic dose (VAS 3)

Secondary

MeasureTime frame
To assess the sedation score and adverse effectsTimepoint: 1. Sedation assessed by Modified Ramsay sedation scale. 2. Hypotension (decrease in mean arterial pressure below 20% of baseline or systolic pressure less than 90 mmHg) 3. Bradycardia (heart rate less than 50 beats/min) Hemodynamic parameters recorded every 5 minutes during and after study drug administration till 30 minutes. Post 30 minutes recorded every 15 minutes and finally every 30 minutes in postoperative room until recovery from the block.

Countries

India

Contacts

Public ContactSarabjeet Chhabra

Government Medical College and Hospital, Sector-32

manpreetdawar@gmail.com9646121503

Outcome results

None listed

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