Clinical trial NCT04753515: Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Intubation
Keywords: Awake tracheal Intubation
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: blood pressure
timeFrame: During the procedure of general anesthesia induction, expected an average of 20 min
Secondary outcomes:
measure: intubation condition score
timeFrame: During the procedure of general anesthesia induction, expected an average of 20 min
Other outcomes:
measure: degree of coughing
timeFrame: During the procedure of general anesthesia induction, expected an average of 20 min.
measure: heart rate
timeFrame: During the procedure of general anesthesia induction, expected an average of 20 min.
measure: pulse oxygen saturation (SpO2)
timeFrame: During the procedure of general anesthesia induction, expected an average of 20 min.
measure: level of recall
timeFrame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
measure: satisfaction score
timeFrame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
measure: adverse events
timeFrame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: SanQing Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/MJT.0000000000000319.
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.
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.
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.
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.