Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation

NCT04753515 | Completed Phase 4

• 1 other identifier: E2020154
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedation; Intubation

Keywords

Awake tracheal Intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• intubation condition score

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

Other Outcomes (6)

• degree of coughing

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

• heart rate

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

• pulse oxygen saturation (SpO2)

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

Study Arms (2)

Group DMR

ACTIVE COMPARATOR

dexmedetomidine combined with midazolam and remifentanil.

Drug: dexmedetomidine combined with midazolam and remifentanil.

Group PMR

ACTIVE COMPARATOR

propofol combined with midazolam and remifentanil.

Drug: propofol combined with midazolam and remifentanil.

Interventions

dexmedetomidine combined with midazolam and remifentanil. DRUG

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

Group DMR

propofol combined with midazolam and remifentanil. DRUG

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

Group PMR

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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;
• body mass index (BMI) ≥30 kg/m2 or \<18 kg/m2;
• 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);
• Patients with a higher risk of reflux and aspiration, such as full stomach, gastrointestinal obstruction, gastroparesis, and pregnant women;
• Patients have schizophrenia, epilepsy, Parkinson's disease, intellectual disability, hearing impairment.;
• Patients who take sedative and analgesic drugs for a long time;
• Patients who are allergic to propofol, dexmedetomidine, midazolam or remifentanil
• Patients who are expected to be difficult to intubate;
• Patients who are participating in other clinical trials, or who refuse to sign informed consent.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related 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.

  PMID: 23364566 BACKGROUND

• 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.

  PMID: 26196522 BACKGROUND

• 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.

  PMID: 22844277 BACKGROUND

• 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.

  PMID: 27484783 BACKGROUND

• 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.

  PMID: 23512191 BACKGROUND

• 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.

  PMID: 33120766 BACKGROUND

MeSH Terms

Interventions

Midazolam; Remifentanil

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• SanQing Jin, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: March 5, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)