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Comparison of three drugs (tramadol, clonidine and dexmedetomidine)for prevention of shivering after spinal anaesthesia in patients undergoing surgery for prostate hypertrophy.

Comparison of Intrathecal Tramadol, Clonidine and Dexmedetomidine on Perioperative shivering in patients undergoing TURP under subarachnoid block: A Prospective Randomized Controlled Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012575
Enrollment
160
Registered
2018-03-15
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: null- American Society of Anaesthesiologists Grade I/II/II patients with Benign Prostatic Hypertrophy undergoing Transuretheral resection of Prostate (TURP)

Interventions

Intervention1: Group II: 1.8 ml Hyperbaric bupivacaine 0.5% + 0.2 ml (10 mg) injection tramadol hydrochloride
injected intrathecally. Intervention2: Group III: 1.8 ml Hyperbaric bupivacaine 0.5% + 0.2 ml (30 µg) injection clonidine
injected intrathecally. Intervention3: Group IV: 1.8 ml Hyperbaric bupivacaine 0.5% + 5 µg dexmedetomidine diluted upto 0.2 ml with NS
intejected intrathecally. Control Intervention1: Group I: 1.8 ml Hyperbaric bupivacaine 0.5% + 0.2 ml 0.9% normal saline (NS)
injected intrathecally.

Sponsors

Shri Guru Ram Rai Institute of Medical and Health Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with Benign Prostatic Hypertrophy undergoing TURP.

Exclusion criteria

Exclusion criteria: Patient refusal, Contraindication to SAB, Allergy to any of the study drug, Mitral or aortic stenosis, Unstable coronary artery disease, recent myocardial infarction, Second or third degree heart block, Severe hepatic impairment, and Patients on or vasodilators or medications likely to alter thermoregulation

Design outcomes

Primary

MeasureTime frame
Incidence of ShiveringTimepoint: Intraoperatively and upto 1 hour postoperatively.—

Secondary

MeasureTime frame
Duration of analgesiaTimepoint: Time after completion of intrathecal injection till patient complained of pain NRS more than equal to 4.;Heart rate, blood pressure, core body temperature.Timepoint: Baseline At 5 minute intervals after subarachnoid block for first 15 minutes Every 15 minutes intraoperatively and upto 1 hour postoperatively.;Perioperative complications: hypotension, bradycardia, pruritis, nausea, vomiting, respiratory depression.Timepoint: Intraoperatively and upto 1 hour postoperatively.;SedationTimepoint: Every 15 minutes intraoperatively and upto 1 hour postoperatively.;Subarachnoid block characteristicsTimepoint: Onset of sensory and motor block Duration of sensory and motor block—

Countries

India

Contacts

Public ContactMAYANK GUPTA

Shri Guru Ram Rai Institute of Medical and Health Sciences

drm_gupta@yahoo.co.in8171238996

Outcome results

None listed

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