Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753515
• Other study ID #: E2020154
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation
• Sedation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	During the procedure of general anesthesia induction, expected an average of 20 min.
Other	heart rate	Heart rate shown in the monitor	During the procedure of general anesthesia induction, expected an average of 20 min.
Other	pulse oxygen saturation (SpO2)	SpO2 shown in the monitor	During the procedure of general anesthesia induction, expected an average of 20 min.
Other	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.	postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
Other	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).	postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
Other	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)	postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
Primary	blood pressure	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	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.	During the procedure of general anesthesia induction, expected an average of 20 min