A Study Comparing the Effectiveness and Safety of Fentanyl and Dexmedetomidine Added to Spinal Anaesthesia for Pain Relief in Patients Undergoing Lower Abdominal Surgery

A Randomized Comparative Study to Evaluate the Effects and Safety of Intrathecal Fentanyl Versus Intrathecal Dexmedetomidine as Adjuvants to 0.5 Percent Hyperbaric Levobupivacaine in Patients Undergoing Infraumbilical Surgeries Under Spinal Anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104367

Enrollment

Registered

2026-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: N201- Calculus of ureter Health Condition 2: S723- Fracture of shaft of femur Health Condition 3: S821- Fracture of upper end of tibia Health Condition 4: N70- Salpingitis and oophoritis Health Condition 5: I832- Varicose veins of lower extremities with both ulcer and inflammation

Interventions

Intervention1: Dexmedetomidine + 0.5% Heavy Levobupivacaine: Inj. Dexmedetomidine 5 mcg diluted upto 0.5ml with normal saline added to 3 ml of 0.5% heavy Levobupivacaine intrathecally Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 18-60 years 2) American Society of Anesthesiologist physical status 1 or 2 3) Patients undergoing infraumbilical surgeries

Exclusion criteria

Exclusion criteria: 1. Negative consent by the patient 2. contraindication to spinal anaesthesia , (such as coagulopathy , infection at injection site , hypotension , disease or deformity of spine ) 3. psychiatric patient 4.ASA status III/IV 5. known sensitivity to drug

Design outcomes

Primary

Measure	Time frame
To study the onset, duration and highest level of sensory block along with degree and duration of motor block between two groupsTimepoint: To study the onset, duration and highest level of sensory block along with degree and duration of motor block between two groups at different intervals, that is 0,2,4,6,8,10,15,20,25,30 minutes and post operative period upto 5hrs	—

Secondary

Measure	Time frame
To study the hemodynamic changes occuring among the two study groups after administration of the respective drugs Timepoint: intraoperative period after spinal anaesthesia and post operative period	—

Countries

India

Contacts

Public ContactSapna Bansal

MM Institute of Medical Sciences and Research Centre

hod.anaesthesia@mmumullana.org8168381441

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026