Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation

November 28, 2022 updated by: SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University

Comparison Between Dexmedetomidine and Propofol for Sedation When Combined With Midazolam and Remifentanil During Awake Endotracheal Intubation: A Randomized Double-blind Controlled Study

The purpose of this study is to compare the sedation effect of dexmedetomidine and propofol when they are both combined with midazolam and remifentanil during awake endotracheal intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Awake intubation is one of the best strategy guaranteed by the American Society of Anesthesiologists (ASA) guidelines for the management of patients with anticipated difficult airways. Hemodynamic stability, optimal intubating conditions, patients' comfort, amnesia and preservation of patents' spontaneous respiration are critical for awake intubation. Sedation is one of the key elements for this technique. Intravenous midazolam, propofol, dexmedetomidine and remifentanil are commonly used as sedatives during awake intubation. These agents are not preferred to be used alone but in combination with each other for the purpose of minimizing their respective side effects. The aim of this randomized controlled trial is to compare the safety and effectiveness of dexmedetomidine versus propofol for sedation during awake endotracheal intubation when they are both combined with midazolam and remifentanil.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-65 Years old;
  2. scheduled for elective surgery under general anesthesia with oral tracheal intubation;
  3. The American Society of Anesthesiologists(ASA) grade is I or II, and the cardiac function is 1-2;
  4. Body mass index (BMI) 18-30 kg/m2.

Exclusion Criteria:

  1. Patients have severe cardiac diseases (cardiac function grading greater than grade 3/arrhythmia including sick sinus syndrome, atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature, multiple ventricular premature, ventricular premature R on T, ventricular fibrillation and ventricular flutter/acute coronary syndrome) or respiratory failure or hepatic failure or renal failure;
  2. body mass index (BMI) ≥30 kg/m2 or <18 kg/m2;
  3. Patients with poor blood pressure control (receive regular antihypertensive medical treatment but still have systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg);
  4. Patients with a higher risk of reflux and aspiration, such as full stomach, gastrointestinal obstruction, gastroparesis, and pregnant women;
  5. Patients have schizophrenia, epilepsy, Parkinson's disease, intellectual disability, hearing impairment.;
  6. Patients who take sedative and analgesic drugs for a long time;
  7. Patients who are allergic to propofol, dexmedetomidine, midazolam or remifentanil
  8. Patients who are expected to be difficult to intubate;
  9. Patients who are participating in other clinical trials, or who refuse to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group DMR
dexmedetomidine combined with midazolam and remifentanil.
Drug: dexmedetomidine combined with midazolam and remifentanil.
Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.5 mcg/kg dexmedetomidine over 5 min via separate syringe pumps.
Other Names:
  • dexmedetomidine-midazolam-remifentanil
Active Comparator: Group PMR
propofol combined with midazolam and remifentanil.
Drug: propofol combined with midazolam and remifentanil.
Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.33 mg/kg propoful over 5 min via separate syringe pumps.
Other Names:
  • propofol-midazolam-remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: During the procedure of general anesthesia induction, expected an average of 20 min
systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) shown in the monitor.
During the procedure of general anesthesia induction, expected an average of 20 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation condition score
Time Frame: During the procedure of general anesthesia induction, expected an average of 20 min
Assessment of the intubation condition according to the scale of the modified Erhan's intubation condition score which includes jaw relaxation, laryngoscopy, vocal cord position, and patient's response (coughing, limb movement) to intubation and inflation of the intubation tube cuff.
During the procedure of general anesthesia induction, expected an average of 20 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of coughing
Time Frame: During the procedure of general anesthesia induction, expected an average of 20 min.
Grade assessment of coughing during the peri-intubation period (1 = No cough and limb activity, 2 = Intermittent cough with slight activity of chest and abdomen, 3 = Continuous cough with large amplitude activity of chest and abdomen, no limb activity, 4 = Continuous cough with large amplitude activity of chest and abdomen and limbs)
During the procedure of general anesthesia induction, expected an average of 20 min.
heart rate
Time Frame: During the procedure of general anesthesia induction, expected an average of 20 min.
Heart rate shown in the monitor
During the procedure of general anesthesia induction, expected an average of 20 min.
pulse oxygen saturation (SpO2)
Time Frame: During the procedure of general anesthesia induction, expected an average of 20 min.
SpO2 shown in the monitor
During the procedure of general anesthesia induction, expected an average of 20 min.
level of recall
Time Frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
At the 24-h postoperative follow-up visit, patients will be interviewed to assess their recall of pre-anesthesia events, administration of topical anesthesia, endoscopy and intubation.
postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
satisfaction score
Time Frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
At the 24-h postoperative follow-up visit, patients will be interviewed to assess their satisfaction about the procedure of awake intubation (1 = excellent, 2 = good, 3 = fair, 4 = poor).
postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
adverse events
Time Frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
At the 24-h postoperative follow-up visit, patients will be interviewed to assess the adverse events related to endotracheal intubation (postoperative hoarseness or sore throat)
postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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