A study comparing two intravenous medicines used with spinal anaesthesia to improve pain relief, safety and recovery in lower abdominal and lower limb surgeries.

Comparative study between intravenous dexmedetomidine and intravenous butorphanol as adjuvants to intrathecal bupivacaine in the patients undergoing infraumbilical surgeries under spinal anaesthesia. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099423

Enrollment

Registered

2025-12-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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: Dexmedetomidine: 30 patients will receive 0.2mg/kg bodyweight hyperbaric bupivacaine 0.5% intrathecally and injection dexmedetomidine 1 g/kg in normal saline to make total volume of 10

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-60 years of either sex undergoing spinal anaesthesia for elective infraumbilical surgeries, such as surgical procedures on lower abdomen, genitourinary region (including gynaecological and urological surgeries). 2.Patients of American Society of Anaesthesiologists (ASA) grade I or II. 3.Either sex

Exclusion criteria

Exclusion criteria: 1.Pregnancy. 2.Patient who refuses to give consent. 3.Patients with a history of allergy to the study drugs. 4.Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled thyroid disorder, height more than 180 cm or height less than 140 cms and weight more than 100 kgs or weight less than 45 kgs. 5.Patients with cardiovascular, respiratory, renal, hepatic or neurological disease. 6.Patients contraindicated for spinal anesthesia.

Design outcomes

Primary

Measure	Time frame
To evaluate the effects and compare the onset time of sensory and motor block and duration of analgesia of intravenous dexmedetomidine and butorphanol on spinal anaesthesia with 0.5% hyperbaric bupivacaine.Timepoint: Maximum sensory block level(MSBL) assessed at 2, 4, 6 and minutes. Duration of sensory block: time from MSBL until 4 segments regressions is noted. Motor onset time: The time from drug injection until grade I modified Bromage is achieved. Duration of motor block: time from full intensity motor blockade until modified Bromage 6 is documented.	—

Measure

Time frame

To evaluate the effects and compare the onset time of sensory and motor block and duration of analgesia of intravenous dexmedetomidine and butorphanol on spinal anaesthesia with 0.5% hyperbaric bupivacaine.Timepoint: Maximum sensory block level(MSBL) assessed at 2, 4, 6 and minutes. Duration of sensory block: time from MSBL until 4 segments regressions is noted. Motor onset time: The time from drug injection until grade I modified Bromage is achieved. Duration of motor block: time from full intensity motor blockade until modified Bromage 6 is documented.

—

Secondary

Measure	Time frame
To assess the hemodynamic stability, To identify any adverse effects.Timepoint: SBP,DBP,PR,SPO2 for every 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes from starting.	—

Countries

India

Contacts

Public ContactA Jack Meitei

Regional Institute of Medical Sciences, Imphal

jack2k49@gmail.com8974577889

Outcome results

None listed

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