A Phase 4 interventional study of Dexmedetomidine in Procedural Pain, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 4, Interventional, and Prevention
Skull pin fixation is commonly used in intracranial surgery, which can increase the surgical field of view. Because skull pin fixation is a very irritating and painful medical treatment, it often results in tachycardia (>150-160 beats per min, bpm) and high blood pressure (BP) (>200/120 mmHg). Many strategies to reduce this painful stimulation include oral gabapentin, local injection of local anesthetics, scalp nerve blockade, and deepening the depth of anesthesia. Oral gabapentin must take 2 hr before surgery with many adverse effects such as nausea and vomiting. Local injection of local anesthetics and scalp nerve blockade require injections by neurosurgeons. Due to the manpower and time constraints, neurosurgeons cannot perform the two techniques. Therefore, it depends on anesthesiologists to prescribe more anesthetics to attenuate this intensity painful stimulation. Usually anesthesiologists will give propofol, opioids (fentanyl, alfentanil or remifentanil), α2 agonist (dexmedetomidine or clonidine), add inhalation anesthetics (sevoflurane or desflurane), and finally even use b-blocker to reduce hemodynamic instability (hyperdynamics).
Dexmedetomidine mainly produces a sedative effect by activating α2 adrenergic receptors in the central nervous system. Its α2:α1 ratio is 1620:1, showing high affinity for α2 receptors. Unlike other hypnotic drugs during death, dexmedetomidine keeps the patient in an awakenable state and does not affect respiratory function during sedation. Therefore, general anesthesia can be enhanced, providing sedation and analgesia and improving sleep quality.
Target-controlled infusion (TCI) pump systems can automatically adjust drug infusion rates based on the patient's weight, age, and other physiological parameters to achieve more precise drug concentrations. It can maintain a stable drug concentration and reduce the impact of drug fluctuations on patients, especially when long-term anesthesia or sedation is required. Therefore, using a TCI pump system to administer dexmedetomidine can ensure that the concentration we want can be accurately achieved when performing skull pin fixation. Our hospital has routinely used the Dyck mode of the TCI pump system to infuse dexmedetomidine 0.2-0.4 ng/ml during intracranial surgery.
In view of this, we wanted to observe patients undergoing intracranial surgery with skull pin fixation using the Dyck mode by the TCI pump system under the monitoring of analgesic nociceptive index and hemodynamics. In order to find out the most appropriate dexmedetomidine concentration during skull pin fixation to reduce hemodynamic fluctuations and insufficient pain management as a basis for future anesthesia.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 291 studies on the registry; 58 are open to participants now.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
skull pin fixation
Drug: Dexmedetomidine
The first patient was started on dexmedetomidine Cp 0.4 ng/ml, 2 minutes before the procedure, and the up and down method was used, with the Cp of dexmedetomidine adjusted to 0.05 ng/ml each time. The analgesia nociception index (ANI) during skull pin fixation is lower than (\<) 30 and the heart rate (HR) and arterial blood pressure (ABP) exceed (\>) 20% of the baseline (or the HR is \>100 bpm and the ABP is \>180/100 mmHg), indicating insufficient analgesia or hemodynamics (failure). If the patient is failure for the procedure, increase the Cp by 0.05 ng/ml for the next patient; the ANI is higher than or equal to (≥30) and the HR and ABP do not exceed 20% of the baseline or the HR is ≤100 bpm and the ABP is ≤180 /100 mmHg) indicates that the analgesia and hemodynamic stability are acceptable (success), and the next patient will be adjusted downward by 0.05 ng/ml.
50% effect concentration of dexmedetomidine
50% effect concentration of dexmedetomidine will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
Time frame: up to 15 minutes (peri-fixation period)
95% effect concentration of dexmedetomidine
95% effect concentration of dexmedetomidine will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
Time frame: up to 15 minutes (peri-fixation period)
No study locations are listed for this record.
Start is estimated for Mar 2025; primary completion for Dec 2025, 9 months later.
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Studies of the drug tested here: Dexmedetomidine
Kaohsiung Medical University Chung-Ho Memorial Hospital →