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Comparative study of dexmedetomidine-bupivacaine mixture given in spinal anaesthesia versus bupivacaine spinal anesthesia with intravenous dexmedetomidine

A prospective, randomized and triple-blind study of the effects of intrathecal dexmedetomidine-bupivacaine versus intravenous dexmedetomidine plus intrathecal bupivacaine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023952
Enrollment
80
Registered
2020-03-13
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: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Group A :Intrathecal 0.5% bupivacaine heavy 3.4 ml plus 5 µg dexmedetomidine Group B& C : Intrathecal 0.5% bupivacaine heavy 3.4 ml and Intra venous dexmedetomidine 0.5 µg/Kg bo
Patients in group B will be given intrathecal 0.5% bupivacaine heavy 3.4 ml (17mg) and IV dexmedetomidine 0.5 µg/Kg body weight in 50 ml of normal saline as an IV infusion over 10 minutes, 20 minute

Sponsors

Gayatri vidya parishad Institute of health care and medical technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Study population will consist of Eighty adult patients of age between 18 and 70 years, body weight between 40and 70 Kg, height between 145 and 170 cm and who are of American Society of Anaesthesiologists (ASA) physical status grade I and II of either sex and attending our Medical College Hospital for elective lower limb and lower abdominal surgeries lasting less than 2 hours in duration between the period from 15-3- 2020 to 31-8 -2020 and who do not have our exclusion criteria.

Exclusion criteria

Exclusion criteria: Exclusion criteria adapted for our study include patients with known allergy to study drugs, patient refusal of local anaesthetic block, patients suffering from neurological disorders, psychiatric disorders, mental retardation, uncontrolled hypertension and diabetes mellitus, patients having coagulation or bleeding abnormalities, severe spinal deformity, patients on Calcium channel blockers/angiotensin-converting-enzyme (ACE) inhibitors/clonidine/β-blockers, sedative medications/opioids/antidepressants in the week prior to surgery, infection at spinal injection site or any contraindication to spinal anesthesia. and cases of caesarean section.

Design outcomes

Primary

MeasureTime frame
The primary outcome variables studied will be the differences in the duration of the sensory and motor blocks.Timepoint: Duration of sensory block will be assessed when the patient complains of pain after recovery from the spinal block Duration of motor block will be assessed when the patient recovers complete motor function after the spinal block

Secondary

MeasureTime frame
The secondary outcome variables studied will be differences in the onset of block both motor and sensory, haemodynamic variables heart rate (HR), mean arterial pressure (MAP),systolic blood pressure (SBP) diastolic blood pressure( DBP), respiratory rate (RR) and Peripheral arterial oxygen saturation (SaO2),Timepoint: every 5 min for the initial 30 min and later at every 15 min till the end of surgery and at every 30 minutes till the recovery of sensory and motor block.

Countries

India

Contacts

Public ContactRamana Reddy MV

Gayatri Vidya Parishad Institute of Health Care and Medical Technology

drramanareddymoolagani@gmail.com9908232415

Outcome results

None listed

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