CClinicalTrials.gg
Sign In
CompletedNCT04753515Updated Nov 30, 2022

Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation

A Phase 4 interventional study of dexmedetomidine combined with midazolam and remifentanil. and propofol combined with midazolam and remifentanil. in Sedation and Intubation, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Sedation
  • Intubation

Keywords

  • Awake tracheal Intubation
03

In context

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Group DMR

    dexmedetomidine combined with midazolam and remifentanil.

    Drug: dexmedetomidine combined with midazolam and remifentanil.

  • Active comparator
    Group PMR

    propofol combined with midazolam and remifentanil.

    Drug: propofol combined with midazolam and remifentanil.

Interventions

  • Drugdexmedetomidine 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.

    Also known as: dexmedetomidine-midazolam-remifentanil

  • Drugpropofol 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.

    Also known as: propofol-midazolam-remifentanil

06

What researchers measure

Primary outcomes

  1. blood pressure

    systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) shown in the monitor.

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min

Secondary outcomes

  1. intubation condition score

    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.

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min

Other outcomes

  1. degree of coughing

    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)

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min.

  2. heart rate

    Heart rate shown in the monitor

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min.

  3. pulse oxygen saturation (SpO2)

    SpO2 shown in the monitor

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min.

  4. level of recall

    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.

    Time frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

  5. satisfaction score

    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).

    Time frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

  6. adverse events

    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)

    Time frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

07

Study locations

1 site
  • the Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
08

References and documents

Publications

  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available. PubMed 23364566 ↗
  • Zhou LJ, Fang XZ, Gao J, Zhangm Y, Tao LJ. Safety and Efficacy of Dexmedetomidine as a Sedative Agent for Performing Awake Intubation: A Meta-analysis. Am J Ther. 2016 Nov/Dec;23(6):e1788-e1800. doi: 10.1097/MJT.0000000000000319. PubMed 26196522 ↗
  • Cattano D, Lam NC, Ferrario L, Seitan C, Vahdat K, Wilcox DW, Hagberg CA. Dexmedetomidine versus Remifentanil for Sedation during Awake Fiberoptic Intubation. Anesthesiol Res Pract. 2012;2012:753107. doi: 10.1155/2012/753107. Epub 2012 Jul 16. PubMed 22844277 ↗
  • Xu T, Li M, Ni C, Guo XY. Dexmedetomidine versus remifentanil for sedation during awake intubation using a Shikani optical stylet: a randomized, double-blinded, controlled trial. BMC Anesthesiol. 2016 Aug 2;16(1):52. doi: 10.1186/s12871-016-0219-9. PubMed 27484783 ↗
  • Johnston KD, Rai MR. Conscious sedation for awake fibreoptic intubation: a review of the literature. Can J Anaesth. 2013 Jun;60(6):584-99. doi: 10.1007/s12630-013-9915-9. Epub 2013 Mar 20. PubMed 23512191 ↗
  • Park S, Choi SL, Nahm FS, Ryu JH, Do SH. Dexmedetomidine-remifentanil vs propofol-remifentanil for monitored anesthesia care during hysteroscopy: Randomized, single-blind, controlled trial. Medicine (Baltimore). 2020 Oct 23;99(43):e22712. doi: 10.1097/MD.0000000000022712. PubMed 33120766 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04753515
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
SanQing Jin (professor, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Feb 15, 2021
Start date
Mar 5, 2021
Primary completion
May 1, 2021
Completion
May 1, 2021
Last update
Nov 30, 2022

Study contacts

SanQing Jin, MD
principal investigator · The Sixth Affiliated Hospital, Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Start the discussion