jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

Jan. 30, 2024

Jan. 26, 2026

jRCT1031230607

Effects of general anesthesia induction on intracranial pressure: Comparison between propofol and remimazolam

General anesthesia induction and intracranial pressure

Jan. 20, 2026

35

Thirty-five patients with an American Society of Anesthesiologists (ASA) physical status of I-II were allocated to either the propofol group (n=17) or the remimazolam group (n=18), and the effects of induction of general anesthesia on intracranial pressure were examined.

Of the target 46 patients, informed consent was obtained from 40, and data collection was completed in 35. Among those who provided consent, one patient developed a fever after consent was obtained and the surgery was postponed; therefore, data collection was discontinued. In addition, data collection was discontinued in four patients due to device-related problems during measurement.

No severe adverse events were observed in this study.

Primary outcome: Intracranial pressure decreased (within the normal range) after induction with propofol, whereas no significant change was observed with remimazolam. Secondary outcomes: Cerebral blood flow decreased with both propofol and remimazolam.

In 17 patients receiving propofol and 18 receiving remimazolam, the effects of induction of general anesthesia on intracranial pressure were examined. Intracranial pressure decreased after induction with propofol, whereas no significant change was observed with remimazolam.

Jan. 26, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1031230607

Ogawa Yojiro

Nihon university school of medicione

30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo

+81-3-3972-8111

ogawa.yojiro@nihon-u.ac.jp

Ogawa Yojiro

Nihon university school of medicione

30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo

+81-3-3972-8111

ogawa.yojiro@nihon-u.ac.jp

Complete

Jan. 30, 2024

Feb. 15, 2024
46

Interventional

randomized controlled trial

double blind

uncontrolled control

parallel assignment

prevention purpose

1. Healthy adult consented to participate in this study.
2. Patients with an American Society of Anesthesiologists pre-anesthesia risk rating of 2 or less
3. Patient who can be obtained cerebral blood flow velocity signal by transcranial Doppler ultrasonography.

1. Patients who refuse to participate in the study.
2. Patients who are deemed inappropriate as research subjects by the principal investigator.
3. Patients with a history of allergy to general anesthetic or food (dairy and soybean).
4. Patients with an American Society of Anesthesiologists pre-anesthesia risk rating of 3 or more.
5. Patients who have cerebrovascular disorder and an abnormal value of the intracranial pressure.
6. Patients undergoing an epidural or a peripheral nerve block with general anesthesia.

18age old over
65age old under

Both

Patients undergoing general anesthesia

The study is randomized between propofol and lemimazolam anesthesia.

General Anesthesia

Intracranial Pressure, Propofol, Remimazolam.

D000768

D007427, D015742, C522201

Intracranial Pressure

Cerebral blood flow, vaital sign, autonomic nerve activity, circulatory regulation.

Nihon University Itabashi Hospital
Nihon University Itabashi Hospital, Clinical Research Judging Committee
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo

+81-3-3972-8111

med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval

Jan. 15, 2024

none

History of Changes

No Publication date
4 Jan. 26, 2026 (this page) Changes
3 April. 04, 2024 Detail Changes
2 April. 03, 2024 Detail Changes
1 Jan. 30, 2024 Detail