Skip to content

COMPARISON OF INTRATHECAL FENTANYL, DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO HEAVY BUPIVACAINE FOR LOWER LIMB SURGERY IN ADULT PATIENTS

A RANDOMIZED CONTROLLED STUDY TO COMPARE INTRATHECAL FENTANYL, DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO HYPERBARIC BUPIVACAINE FOR LOWER LIMB SURGERY IN ADULT PATIENTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051460
Enrollment
90
Registered
2023-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: - Health Condition 2: S829- Unspecified fracture of lower leg

Interventions

Intervention1: FENTANYL GROUp: Intrathecally 12.5mg (2.5ml) 0.5% bupivacaine with fentanyl 25mcg(0.5ml) Intervention2: DEXMEDETOMIDINE GROUP: Intrathecally 12.5mg (2.5ml) 0.5% bupivacaine with pre-

Sponsors

Jawaharlal Nehru Medical College AMUAligarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A.S.A I & II Patients Patients planned for elective lower limb surgery under Sub-Arachnoid Block

Exclusion criteria

Exclusion criteria: 1)Patients with contraindications to regional anaesthesia 2)Patients with disease like diabetes ,peripheral neuropathy. 3)Patients with history of coexisting diseases like ischaemic heart diseases, hypertension, impaired renal functions, rheumatoid arthritis and severe liver diseases . 4)Patients with known allergy to local anaesthetic 5) pregnant patients, chronic alcoholics, AV Blocks, incomplete heart blocks , intake of alpha-blockers.

Design outcomes

Primary

MeasureTime frame
Duration of sensory and motor blockTimepoint: The duration of sensory block was defined as the time of regression of two segments in the maximum block height, evaluated by pinprick. Duration of motor block was defined as time from which patient acheive modified bromage 3 to modified bromage 0.

Secondary

MeasureTime frame
1.Onset of sensory and motor block 2.Time to two segments regressions of block 3.Duration of Spinal Anaesthesia in each group 4.To compare the hemodynamic changes among three groups: a) Heart Rate(HR) b)Mean Arterial Pressure(MAP). 5. Perioperative Ramsay Sedation Score 6. Complications (nausea, vomiting , pruritis) Timepoint: The onset of sensory block was defined as the time between injection of intrathecal anesthetic and the absence of pain at the T8 dermatome assessed by sterile pinprick every 2 min till T8 dermatome was achieved. Time for motor block onset was defined as modified Bromage score of 3. The duration of spinal anesthesia shall be defined as the period from spinal injection to the first occasion when the patient complained of pain in the postoperative period.

Countries

India

Contacts

Public ContactUmar Sherwani

Jawaharlal Nehru Medical College, Aligarh Muslim University

syedkamranhabib@gmail.com9897172780

Outcome results

None listed

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