A Phase 4 interventional study of Scalp block with 0.5% plain Marcaine and Scalp block with 0.9% normal saline in Brain Tumour, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by Chiang Mai University · Phase 4, Interventional, and Treatment
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).
A Prospective Randomized Double Blind Control
1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.
This study's enrollment of 100 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Anterior scalp block with 0.5% plain Marcaine 20 ml.
Drug: Scalp block with 0.5% plain Marcaine
Anterior scalp block with 0.9% normal saline 20 ml.
Drug: Scalp block with 0.9% normal saline
Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.
Also known as: Code 1
Anterior scalp block will be done by using 0.9% normal saline 20 ml.
Also known as: Code 2
Intraoperative opioid consumption
The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.
Time frame: During the supratentorial craniotomy surgery
systolic blood pressure change
The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded. The systolic blood pressure change from baseline will be calculated. The unit is mmHg.
Time frame: within 5 minutes after skull pin insertion
Heart rate change
The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded. The heart rate change from baseline level will be calculated. The unit is beats per minute.
Time frame: within 5 minutes after skull pin insertion
extubation
The rate of immediate extubation before transferring to the intensive care unit (ICU) compared between patients who received 0.5% plain Marcaine and 0.9% normal saline solution.
Time frame: end of surgery, before transferring to the intensive care unit
Plan to share: No
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Chiang Mai University