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The effects of dexmedetomidine and fentanyl infusion on stress response to skull pin insertion in elective craniotomy: A randomized double-blind controlled trial

The effects of dexmedetomidine and fentanyl infusion on stress response to skull pin insertion in elective craniotomy: A randomized double-blind controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260708010
Enrollment
60
Registered
2026-07-08
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Skull pin insertion is a highly noxious stimulus that can provoke significant stress and hemodynamic changes. If anesthesiologist cannot control or attenuate this response during craniotomy operation, it could be make an adverse effects such as intracranial hemorrhage or myocardial infarction. Craniotomy, skull-pin head-holder insertion, Hemodynamic response, metabolic response, dexmedetomidine, fentanyl, cortisol, plasma glucose level, cytokine, neutrophil to lymphocyte ratio (NLR)

Interventions

The dexmedetomidine group received a loading dose of dexmedetomidine 0.5 mcg/kg over 10 minutes before induction of general anesthesia, followed by an infusion of 0.5 mcg/kg/h until 30 minutes after s
Experimental Drug,Active Comparator Drug
Dexmeditomidine,fentanyl

Sponsors

The Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.The patients who were scheduled for elective craniotomy, 2.ASA physical status 1-2

Exclusion criteria

Exclusion criteria: 1.Allergy to dexmeditomidine, fentanyl or any medications for general anesthesia, 2.Bradycardia heart rate below 60bpm or current beta blocker medication, 3.Current clonidine medication, 4.Glasgow coma scale below 15, 5.Alcohol or substance abuse, 6.Pregnancy or breast feeding, 7.Psychological disorder

Design outcomes

Primary

MeasureTime frame
Cortisol level 30 minutes after skull pin insertion Change in cortisol level

Secondary

MeasureTime frame
Hemodynamics responses 30 minutes after skull pin insertion blood pressure, heart rate,,Glucose 30 minutes after skull pin insertion Change in blood glucose level,N:L ratio 30 minutes after skull pin insertion change in neutrophil and lymphocyte ratio

Countries

Thailand

Contacts

Public ContactKornkamon Yuwapattanawong

Chulalongkorn memorial hospital

kornkamon.yu@gmail.com0634628232

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026