Drug Intervention of Spontaneous Hyperventilation in Patients With Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT04940273

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-03-31

Brief Summary

Although spontaneous hyperventilation patients with aneurysmal subarachnoid hemorrhage closely associated with poor outcomes, the standard therapy remains unavailable. Remifentanil has the pharmacological characterization of respiratory inhibition, mainly prolonging the expiratory time and decreasing the respiratory rate while preserving the respiratory drive. The investigators hypothesis that spontaneous hyperventilation could be corrected by titrating the dose of remifentanil and cerebral blood flow will augment during this process.

Detailed Description

Evidence has shown a high incidence of spontaneous hyperventilation in patients with aneurysmal subarachnoid hemorrhage (aSAH), which is associated with poor outcomes. It's well established that the hypocapnia caused by hyperventilation leads to cerebral vasoconstriction, reduces the cerebral blood flow, and decreases the cerebral blood volume and intracranial pressure consequently. However, persistent cerebral vascular constriction increases the risk of cerebral ischemia; therefore, maintaining a partial pressure of arterial carbon dioxide (PaCO2) in the range of 35-40mmHg is recommended to minimize the hazard hypocapnia.

There's still no standard method to deal with spontaneous hyperventilation. Based on the pharmacology and clinical experience, remifentanil seems to be an ideal choice since it could inhibit the respiratory rate in a dose-dependent fashion. As one of the most used short-acting opioids, remifentanil could prolong the expiratory time, meanwhile not influencing the inspiratory time and respiratory drive, consequently decreasing respiratory rate and maintaining the tidal volume.

In this exploratory physiology study, the investigators will test the hypothesis that spontaneous hyperventilation could be suppressed by titrating the dose of remifentanil and could be realized as the target of PaCO2. The investigators will determine the optimal amount of remifentanil, which fulfills the criteria of efficacy and safety, and evaluate its effect on the cerebral blood flow velocity of both the middle cerebral artery and internal carotid artery.

Conditions

Hyperventilation; Aneurysmal Subarachnoid Hemorrhage; Cerebral Blood Flow

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

remifentanil

Continuous infusion of remifentanil at a dose of 0.02、0.04、0.06、0.08 ug/kg/min for 30 minutes in sequence.

Group Type: EXPERIMENTAL

Remifentanil Injection [Ultiva]

Intervention Type: DRUG

Continuous infusion of remifentanil at a dose of 0.02、0.04、0.06、0.08 ug/kg/min for 30 minutes in sequence.

Interventions

Remifentanil Injection [Ultiva]

Continuous infusion of remifentanil at a dose of 0.02、0.04、0.06、0.08 ug/kg/min for 30 minutes in sequence.

Intervention Type: DRUG

Other Intervention Names

remifentanil hydrochloride for injection

Eligibility Criteria

Inclusion Criteria

• Aneurysmal subarachnoid hemorrhage, after craniotomy or clipping
• Arterial blood gas satisfy with PaCO2<35mmHg and pH>7.45
• Presence of an endotracheal tube
• Assisted ventilation mode,CPAP/PSV
• ICP monitoring

Exclusion Criteria

• Age <18 years
• Pregnancy
• Chronic obstructive pulmonary disease
• Allergy to opioids
• Clinically relevant hepatic or renal failure
• Hemodynamic instability
• TCD windows cannot detect cerebral blood flow
• Refuse to participate the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

department head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhou Jian-Xin, MD

Role: STUDY_DIRECTOR

Capital Medical University

Locations

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhou Jian-Xin, MD

Role: CONTACT

zhoujx.cn@gmail.com

010-59976518

Li Hong-Liang, MD

Role: CONTACT

arnold_lhl@126.com

15910678616

Facility Contacts

Jian-Xin Zhou, MD

Role: primary

zhoujx.cn@gmail.com

References

Su R, Zhou J, Zhu N, Chen X, Zhou JX, Li HL. Efficacy and safety of remifentanil dose titration to correct the spontaneous hyperventilation in aneurysmal subarachnoid haemorrhage: protocol and statistical analysis for a prospective physiological study. BMJ Open. 2022 Nov 9;12(11):e064064. doi: 10.1136/bmjopen-2022-064064.

Reference Type: DERIVED

PMID: 36351728 (View on PubMed)

Other Identifiers

KY2021-001

Identifier Type: -

Identifier Source: org_study_id