Treatment of Spontaneous Hyperventilation With Remifentanil in Traumatic Brain Injury Patients

NCT04974060 | Unknown

• 1 other identifier: KY2021-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous hyperventilation is common in severe traumatic brain injury patients and correlates closely with poor outcomes. How to treat this pathological condition remain unsolved. Remifentanil is a frequently used short-acting opioid, has the potent side-effect of dose-dependent respiratory inhibition. Specifically, it prolongs the expiratory time only and does not influence the respiratory drive. Among the safety range, the investigators will determine an ideal dose of remifentanil to maintain PaCO2 between 35 to 45 mmHg. The investigators will monitor the cerebral blood flow of the middle cerebral artery and the internal carotid artery to validate cerebral perfusion improvement.

Conditions

Hyperventilation; Traumatic Brain Injury

Keywords

Spontaneous Hyperventilation; Severe Traumatic Brain Injury; 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 severe traumatic brain injury

  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).

  Baseline and 30 minutes following each infusion rate adjustment (0.02, 0.04, 0.06, and 0.08 μg/kg/min)

Secondary Outcomes (1)

• To explore the effect of remifentanil on the cerebral blood flow in patients with severe traumatic brain injury at the different dose of remifentanil

  Baseline and 30 minutes following each infusion rate adjustment (0.02, 0.04, 0.06, and 0.08 μg/kg/min)

Study Arms (1)

Remifentanil intervention

EXPERIMENTAL

After the satisfactory analgesia and sedation, remifentanil will continuously infuse an escalating dose in the sequence of 0.02, 0.04, 0.06, and 0.08 μg/kg/min, each dose infusion lasting at least 30 minutes.

Drug: Remifentanil Injection

Interventions

Remifentanil Injection DRUG

Dilute 2mg Remifentanil with normal saline to 50 ml (40ug/ml) and continuously intravenous infused at the doses of 0.02, 0.04, 0.06, and 0.08 μg/kg/min for each lasting 30 minutes.

Also known as: remifentanil hydrochloride for injection

Remifentanil intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Severe TBI (3 \< glasgow coma scale (GCS) ≤ 8)
• Hyperventilation (PaCO2 \< 35 mmHg and pondus hydrogenii (pH) \> 7.45)
• Presence of an endotracheal tube
• Assisted ventilation mode (CPAP/PSV)

You may not qualify if:

• Induced/iatrogenic hyperventilation
• No informed consent was signed
• Transcranial doppler sonography (TCD) data collection cannot be completed due to anatomical structure
• Severe multiple organ failure, persistent high fever, massive thoraco-peritoneal effusion
• Medical history of major craniocerebral injury and chronic obstructive pulmonary disease (COPD)
• Conformed or Suspected history of opioid-related adverse reactions
• Withdraw from the study due to the change of patient's condition and other methods of treatment and intervention are needed

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Hyperventilation; Brain Injuries, Traumatic

Interventions

Remifentanil; Injections

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

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

• Jian-Xin Zhou, MD

  Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

010-59978019; zhoujx.cn@gmail.com

Hong-Liang Li, 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: Professor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: July 23, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 31, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)