Aneurysmal Subarachnoid Hemorrhage Clinical Trial
Official title:
Intervention of Spontaneous Hyperventilation in Patients With Aneurysmal Subarachnoid Hemorrhage: the Feasibility of Drug Therapy and Its Impact on Cerebral Blood Flow
NCT number | NCT04940273 |
Other study ID # | KY2021-001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | March 31, 2022 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | ICU, Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To explore the effect of remifentanil on the cerebral blood flow in patients with aSAH at the different dose | The differences of mean cerebral flow velocity (MFV) of middle cerebral artery and Internal carotid artery between baseline and 30 minutes following each infusion rate adjustment of remifentanil were recorded to determine the change of cerebral blood flow. | The MFV at baseline and 30 minutes following each infusion rate adjustment (0.02?0.04?0.06?0.08µg/kg/min) |
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