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A study to compare the effectiveness of injecting drug bupivacaine versus bupivacaine plus dexmedetomidine in the skin of head to reduce the rise in blood pressure and heart rate during head surgeries

A study to compare efficacy of scalp infiltration of bupivacaine and bupivacaine plus dexmedetomidine to blunt hemodynamic response to craniotomy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050630
Enrollment
60
Registered
2023-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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: Bupivacaine plus dexmedetonidine: 2mg/kg of 0.25% bupivacaine plus 1microgram/kg of dexmedetomidine will be infilterated in scalp before skin incision and pin insertion and will observe

Sponsors

PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American Society of Anesthesiologists (ASA) physical status I, II & III, scheduled to undergo craniotomy for tumor, aneurysm, tuberculoma, to remove epileptic focus etc. and who are able to understand the study protocol will be included in the study.

Exclusion criteria

Exclusion criteria: The patients who ï?¬ History of hypertension, diabetes mellitus and cardiovascular disease ï?¬ Local anaesthetic allergy ï?¬ Allergy to dexmedetomidine ï?¬ are not willing to give consent will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of scalp infiltration of bupivacaine and bupivacaine plus dexmedetomidine before skin incision and pin insertion on heart rate and mean arterial pressure.Timepoint: Heart rate and blood pressure will be recorded at Eight time points: 1) At baseline after the induction of anesthesia; 2) after pin insertion; 3) after scalp incision; 4) during dural opening 5) during dural closure; 6) during skin closure; 7) on admission to the post aneasthesia care room (PACU); and 8) 2 h after admission to the PACU.

Secondary

MeasureTime frame
To observe side effects of the study drugs used.Timepoint: At any point of time intraoperatively and postoperatively

Countries

India

Contacts

Public ContactGeeta Choudhary

PGIMS Rohtak

gcgeetsj0@gmail.com8301992136

Outcome results

None listed

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