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A trial to study the effect of two agents, Dexmedetomidine and midazolam for the control of pain occurring after surgery

Comparison of the effects of addition of midazolam (or) dexmedetomidine versus placebo to intrathecal bupivacaine on post operative analgesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/06/004706
Enrollment
90
Registered
2014-06-26
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: null- Scheduled for elective endourological procedures,perianal surgeries,inguinal hernia, and infra umbilical surgery under spinal anaesthesia

Interventions

Intervention1: Dexmedetomidine-Bupivacaine: Dose:3ml of 0.5% hyperbaric bupivacaine combined with 5mcg of preservative free dexmedetomidine and made to a total volume of 3.5 mL Frequency:Single Route:

Sponsors

SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists physical status I/ II patients scheduled for elective endourological procedures under planned spinal anaesthesia were screened to participate. Patients were included if they are willing to participate in the study and able to understand and use numeric rating pain scale to evaluate their own pain intensity.

Exclusion criteria

Exclusion criteria: Past history of spine surgery Infection focus at back Coagulopathy Hypersensitivity to local anaesthetics or study drugs On chronic analgesic therapy

Design outcomes

Primary

MeasureTime frame
comparison of the duration of pain free post operative period(Time to first analgesic request) among Bupivacaine-Dexmedetomidine,Bupivacaine-Midazolam and Bupivacaine-Normal saline group.Timepoint: The numeric rating scale was used to assess pain at 0,2, 4, 6, 8, 12, and 24th hours of the postoperative period.—

Secondary

MeasureTime frame
hypotension, bradycardia, respiratory depression (respiratory rate 8 per minunte)Timepoint: Intraoperative period 0,2, 4, 6, 8, 12, and 24th hours of the postoperative period.;Nausea and vomiting, headache, and urinary dysfunctionTimepoint: Upto 24 hours after surgery;Ramsay sedation score (1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to painTimepoint: 15min,45minute after spinal anaesthesia and at the end of the surgery—

Countries

India

Contacts

Public ContactAloka Samantaray

Sri Venkateswara Institute of Medical Sciences

aloksvims@gmail.com9490713247

Outcome results

None listed

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