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Comparison of Sterile Silicone studs and Scalp Infiltration with lignocaine in attenuation of hemodynamic response to skull pin insertion during craniotomy

Comparison of Sterile Silicone studs and Scalp Infiltration with lignocaine in attenuation of hemodynamic and stress response to skull pin insertion during craniotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043584
Enrollment
120
Registered
2022-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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: 2% lignocaine to be given locally at pin site insertion: Dose used of 2% lignocaine will be 1.5mg/kg. Frequency will be once only at the time of pin insertion. Duration will be till the

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA I and II patient 2) Age between 18 years to 65 years 3) Male or Female

Exclusion criteria

Exclusion criteria: 1) Patient refusal. 2) Inability to give informed consent 3) Patient with H/o Uncontrolled Hypertension or Bradycardia ; Ischemic heart disease ; Heart block ; being on Beta Adrenergic Blocker ; allergy to medication including propofol,fentanyl and dexmetomidine. 4) Any unconsious patient.

Design outcomes

Primary

MeasureTime frame
Comparison of Sterile Silicone studs and Scalp Infiltration with lignocaine in attenuation of hemodynamic and stress response to skull pin insertion during craniotomy. Outcomes to be studied are changes in HR and MAP after pin insertion in both the groups.Timepoint: T1- BASELINE BP AND HR T2- 1 MIN PRIOR TO PIN INSERTION T3- 1 MIN AFTER PIN INSERTION T4- 2 MIN AFTER PIN INSERTION T5- 3 MIN AFTER PIN INSERTION T6- 4 MIN AFTER PIN INSERTION T7- 5 MIN AFTER PIN INSERTION—

Secondary

MeasureTime frame
TO assess the amount of rescue drug used in form of fentanyl in both the groups. To assess incidence of anyany associated complications with pin insertion like bleeding, hemotoma formation, venous air embolism, skull fractures.Timepoint: T1- BASELINE BP AND HR T2- 1 MIN PRIOR TO PIN INSERTION T3- 1 MIN AFTER PIN INSERTION T4- 2 MIN AFTER PIN INSERTION T5- 3 MIN AFTER PIN INSERTION T6- 4 MIN AFTER PIN INSERTION T7- 5 MIN AFTER PIN INSERTION—

Countries

India

Contacts

Public ContactDr Rajeev Chauhan

PGIMER , Chandigarh

dr.rajeevchauhan@gmail.com7087422950

Outcome results

None listed

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