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Clinical observation of sodium hydroxybutyrate combined with remifentanil anesthesia in neurosurgery

Clinical observation of sodium hydroxybutyrate combined with remifentanil anesthesia in neurosurgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110811
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Neurosurgical disorders

Interventions

Test group:Sedation with sodium hydroxybutyrate during induction of anesthesia
Control Group:Sedation with propofol during induction of anesthesia

Sponsors

Capital University of Medical Sciences Sambo Brain Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Patients who need tracheal intubation and general anesthesia for selective neurosurgical operations; (2) American Society of Anesthesiologists (ASA) Class I-II; (3) Aged 18-60(including 18 and 60 years old) , male or female; (4) Subjects voluntarily participated in the study and signed a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with hypokalemia; (2) Patients with heart block and bradycardia (heart rate < 50 beats/min) ; (3) Patients with a history of asthma, epilepsy, etc. ; (4) Patients with a history of drug allergy; (5) Patients with difficult airways; (6) Patients who recently participated in another clinical study.

Design outcomes

Primary

MeasureTime frame
The difference between the mean arterial pressure immediately before endotracheal intubation and the baseline mean arterial pressure before induction of anesthesia was measured in all patients;

Secondary

MeasureTime frame
General information of the patient included gender, age, height, weight, BMI, and Asa Class;Before anesthesia induction (T 0) , immediately after ciliary reflex disappeared (t 1) , immediately before endotracheal intubation (t 2) , immediately after endotracheal intubation (t 3) , 1 min after endotracheal intubation (t 4) , 3 min after endotracheal intubation (t 5) , 5 min after endotracheal intubation (t 6) , 10 min after endotracheal intubation (t 7) were recorded in each time point of NIBP, HR, SpO2, RE, SE, SV, CO, SVR.;The time from induction of anesthesia to disappearance of oral command, disappearance of eyelash reflex and entropy index (RE) < 60 were recorded.;The use of vasoactive drugs during anesthesia induction was recorded.;The occurrence of adverse reactions such as injection pain, bradycardia (heart rate < 50 bpm) , hypotension (MAP =65 mm Hg or decreased by more than 20% of the baseline value) , and hypertension (MAP increased by more than 20% of the baseline value) were recorded.;The number of cases in each group was recorded.;The occurrence of adverse reactions such as nausea and vomiting during the 24-hour postoperative follow-up was recorded.;

Countries

China

Contacts

Public ContactWang Baoguo

Capital University of Medical Sciences Sambo Brain Hospital

wbgttyy@163.com+86 133 7018 5075

Outcome results

None listed

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