Drug Intervention of Spontaneous Hyperventilation in Patients With Aneurysmal Subarachnoid Hemorrhage

NCT04940273 | Unknown

• 1 other identifier: KY2021-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperventilation; Aneurysmal Subarachnoid Hemorrhage; Cerebral Blood Flow

Keywords

spontaneous hyperventilation; aneurysmal subarachnoid hemorrhage; cerebral blood flow; remifentanil; partial pressure of carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Explore the effective and safe dose of remifentanil to correct spontaneous hyperventilation in patients with aSAH

  The differences of partial pressure of carbon dioxide (PaCO2; mmHg) between the respective points (baseline and 30 minutes following each infusion rate adjustment of remifentanil) were recorded to determine the change of PaCO2 (mmHg).

  The PaCO2 (mmHg) at baseline and 30 minutes following each infusion rate adjustment (0.02、0.04、0.06、0.08μg/kg/min)

Secondary Outcomes (1)

• To explore the effect of remifentanil on the cerebral blood flow in patients with aSAH at the different dose

  The MFV at baseline and 30 minutes following each infusion rate adjustment (0.02、0.04、0.06、0.08μg/kg/min)

Study Arms (1)

remifentanil

EXPERIMENTAL

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

Drug: Remifentanil Injection [Ultiva]

Interventions

Remifentanil Injection [Ultiva] 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.

Also known as: remifentanil hydrochloride for injection

remifentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36351728 DERIVED

MeSH Terms

Conditions

Hyperventilation; Subarachnoid Hemorrhage

Interventions

Remifentanil; Injections

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zhou Jian-Xin, MD

  Capital Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhou Jian-Xin, MD

CONTACT

010-59976518; zhoujx.cn@gmail.com

Li Hong-Liang, MD

CONTACT

15910678616; arnold_lhl@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department head

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 25, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)