Comparing the effectiveness of Dexmedetomidine and Fentanyl as adjunct for Spinal Anaesthesia in term of sensation and ability to move lower limb in Leg Surgeries

To compare the efficacy of dexmedetomidine versus fentanyl as adjuvants to intrathecal hyperbaric bupivacaine in lower limb surgeries - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098529

Enrollment

Registered

2025-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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: Spinal Anaesthesia: The patient will be positioned either sitting or in the lateral decubitus position based on their comfort and the ease of anatomical access. Strict aseptic measures

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA Grade I and II 2.scheduled for elective surgery under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1.Contraindications to regional anesthesia. 2.Drug allergy to study drugs 3.Significant co-morbidities (e.g., IHD, renal/liver dysfunction, AV block). 4.Pregnancy, chronic alcoholism, malnutrition. 5.Neuropsychiatric disorders or communication problems 6.Refusal for study

Design outcomes

Primary

Measure	Time frame
To find and compare the onset of sensory, motor, intraoperative hemodynamics variation, and block regression times.Timepoint: Sensory block assessed at every one minute until the maximum sensory level is reached. Motor level assessment conducted at every one minute until the maximum level reached. Continuous intraoperative vitals will be recorded every 5 min interval for first 15 min and then at 15 min interval till the end of surgery. The sensory level will be checked every 15 minutes to monitor the regression until it reaches two segments below the highest level achieved.	—

Measure

Time frame

To find and compare the onset of sensory, motor, intraoperative hemodynamics variation, and block regression times.Timepoint: Sensory block assessed at every one minute until the maximum sensory level is reached. Motor level assessment conducted at every one minute until the maximum level reached. Continuous intraoperative vitals will be recorded every 5 min interval for first 15 min and then at 15 min interval till the end of surgery. The sensory level will be checked every 15 minutes to monitor the regression until it reaches two segments below the highest level achieved.

—

Secondary

Measure	Time frame
Determining the duration of postoperative analgesia provided by the adjuvants.Timepoint: Pain intensity will be assessed at 4, 8, 12, & 24 hours postoperatively.	—

Countries

India

Contacts

Public ContactDr Mohinder Singh

Sri Guru Ram Das Institute of Medical Sciences and Research

pooja.monga259@gmail.com8968088773

Outcome results

None listed

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