Compatible Effect of Remimazolam Besylate Combined With Afentanil for ATI

NCT06026566 | Unknown DMC

• 1 other identifier: TongjiHospital-Anes QQ01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To study the pharmacokinetics between remimazolam besylate and alfentanil;
2. 2.To determine the optimal dosage of the two drugs in awake endotracheal intubation;
3. 3.To provide clinical guidance for awake endotracheal intubation.

Conditions

Remimazolam; Awake Endotracheal Intubation

Keywords

Remimazolam; Awake Endotracheal Intubation

Outcome Measures

Primary Outcomes (5)

• Respiratory Rate

  RR≤8bpm means respiratory rate decreased after the use of Remimazolam Besylate and Afentanil.

  During surgery

• Tidal volume

  Vt≤5ml/kg means tidal volume decreased after the use of Remimazolam Besylate and Afentanil.

  During surgery

• Deep breathing

  Breathing hard and deep, and then PetCO2≥55mmHg mean deep breathing after the use of Remimazolam Besylate and Afentanil.

  During surgery

• Airway obstruction

  Difficulty in ventilation means airway obstruction after the use of Remimazolam Besylate and Afentanil.

  During surgery

• Oxygen saturation decreased

  SpO2≤94% means oxyfen saturation decreased after the use of Remimazolam Besylate and Afentanil.

  During surgery

Secondary Outcomes (5)

• Airway status

  During surgery

• Intubation response

  During surgery

• RASS score

  During surgery

• Hemodynamic assessments

  During surgery

• The satisfaction of patients and anesthesiologists

  Up to 2 hours after surgery

Study Arms (6)

Dos of R 0.1

EXPERIMENTAL

The dosage of Remimazolam Besylate is 0.1 mg/kg

Drug: Dos of Afentanil 50; Drug: Dos of Afentanil 60; Drug: Dos of Afentanil 70; Drug: Dos of Afentanil 80; Drug: Dos of Afentanil 90; Drug: Dos of Afentanil 100

Dos of R 0.15

EXPERIMENTAL

The dosage of Remimazolam Besylate is 0.15 mg/kg

Drug: Dos of Afentanil 40; Drug: Dos of Afentanil 50; Drug: Dos of Afentanil 60; Drug: Dos of Afentanil 70; Drug: Dos of Afentanil 80; Drug: Dos of Afentanil 90

Dos of R 0.2

EXPERIMENTAL

The dosage of Remimazolam Besylate is 0.2 mg/kg

Drug: Dos of Afentanil 30; Drug: Dos of Afentanil 40; Drug: Dos of Afentanil 50; Drug: Dos of Afentanil 60; Drug: Dos of Afentanil 70; Drug: Dos of Afentanil 80

Dos of R 0.25

EXPERIMENTAL

The dosage of Remimazolam Besylate is 0.25 mg/kg

Drug: Dos of Afentanil 30; Drug: Dos of Afentanil 40; Drug: Dos of Afentanil 50; Drug: Dos of Afentanil 60; Drug: Dos of Afentanil 70; Drug: Dos of Afentanil 80

Dos of R 0.3

EXPERIMENTAL

The dosage of Remimazolam Besylate is 0.3 mg/kg

Drug: Dos of Afentanil 20; Drug: Dos of Afentanil 30; Drug: Dos of Afentanil 40; Drug: Dos of Afentanil 50; Drug: Dos of Afentanil 60; Drug: Dos of Afentanil 70

Dos of R 0.35

EXPERIMENTAL

The dosage of Remimazolam Besylate is 0.25 mg/kg

Drug: Dos of Afentanil 20; Drug: Dos of Afentanil 30; Drug: Dos of Afentanil 40; Drug: Dos of Afentanil 50; Drug: Dos of Afentanil 60; Drug: Dos of Afentanil 70

Interventions

Dos of Afentanil 20 DRUG

the dosage of Afentanil is 20 ng/ml for TCI

Also known as: Afentanil 20

Dos of R 0.3; Dos of R 0.35

Dos of Afentanil 30 DRUG

the dosage of Afentanil is 30 ng/ml for TCI

Also known as: Afentanil 30

Dos of R 0.2; Dos of R 0.25; Dos of R 0.3; Dos of R 0.35

Dos of Afentanil 40 DRUG

the dosage of Afentanil is 40 ng/ml for TCI

Also known as: Afentanil 40

Dos of R 0.15; Dos of R 0.2; Dos of R 0.25; Dos of R 0.3; Dos of R 0.35

Dos of Afentanil 50 DRUG

the dosage of Afentanil is 50 ng/ml for TCI

Also known as: Afentanil 50

Dos of R 0.1; Dos of R 0.15; Dos of R 0.2; Dos of R 0.25; Dos of R 0.3; Dos of R 0.35

Dos of Afentanil 60 DRUG

the dosage of Afentanil is 60 ng/ml for TCI

Also known as: Afentanil 60

Dos of R 0.1; Dos of R 0.15; Dos of R 0.2; Dos of R 0.25; Dos of R 0.3; Dos of R 0.35

Dos of Afentanil 70 DRUG

the dosage of Afentanil is 70 ng/ml for TCI

Also known as: Afentanil 70

Dos of R 0.1; Dos of R 0.15; Dos of R 0.2; Dos of R 0.25; Dos of R 0.3; Dos of R 0.35

Dos of Afentanil 80 DRUG

the dosage of Afentanil is 80 ng/ml for TCI

Also known as: Afentanil 80

Dos of R 0.1; Dos of R 0.15; Dos of R 0.2; Dos of R 0.25

Dos of Afentanil 90 DRUG

the dosage of Afentanil is 90 ng/ml for TCI

Also known as: Afentanil 90

Dos of R 0.1; Dos of R 0.15

Dos of Afentanil 100 DRUG

the dosage of Afentanil is 100 ng/ml for TCI

Also known as: Afentanil 100

Dos of R 0.1

Eligibility Criteria

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

You may qualify if:

• no predictable difficult airway, Mallampati grade Ⅰ-II;
• deviation from ideal body weight ≤25%;
• \[Ideal weight (kg) = height (cm) -100 (male) or 105 (female)\]
• American Society of Anesthesiologists grade Ⅰ-II;
• Informed consent: voluntarily participate in the trial and sign the informed consent.

You may not qualify if:

• patients with head and neck lesions (including malignant tumors, previous surgery or radiotherapy), limited mouth opening, limited neck extension, obstructive sleep apnea, morbid obesity, and progressive airway injury;
• Relative contraindications: patients with respiratory diseases, allergy to local anesthetics, airway bleeding, and non-cooperation;
• patients known to be allergic to remimazolam besylate or benzodiazepines;
• patients with known allergy to alfentanil or opioids;
• body weight exceeding ±25% of ideal body weight;
• patients with coagulation dysfunction, endocrine diseases or other hemodynamic conditions;
• patients with a history of drug or alcohol dependence;
• Subjects who were deemed unsuitable for the study by the investigators.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (15)

• Bi SS, Deng CH, Zhou TY, Guan Z, Li L, Li HQ, Zhang LP, Yang L, Lu W. Remifentanil-sevoflurane interaction models of circulatory response to laryngoscopy and circulatory depression. Br J Anaesth. 2013 May;110(5):729-40. doi: 10.1093/bja/aes504. Epub 2013 Feb 6.

  PMID: 23388507 RESULT

• Ahmad I, El-Boghdadly K, Bhagrath R, Hodzovic I, McNarry AF, Mir F, O'Sullivan EP, Patel A, Stacey M, Vaughan D. Difficult Airway Society guidelines for awake tracheal intubation (ATI) in adults. Anaesthesia. 2020 Apr;75(4):509-528. doi: 10.1111/anae.14904. Epub 2019 Nov 14.

  PMID: 31729018 RESULT

• Ajay S, Singhania A, Akkara AG, Shah A, Adalja M. A study of flexible fiberoptic bronchoscopy aided tracheal intubation for patients undergoing elective surgery under general anesthesia. Indian J Otolaryngol Head Neck Surg. 2013 Apr;65(2):116-9. doi: 10.1007/s12070-012-0576-8. Epub 2012 Oct 17.

  PMID: 24427550 RESULT

• Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.

  PMID: 29210033 RESULT

• El-Boghdadly K, Onwochei DN, Cuddihy J, Ahmad I. A prospective cohort study of awake fibreoptic intubation practice at a tertiary centre. Anaesthesia. 2017 Jun;72(6):694-703. doi: 10.1111/anae.13844.

  PMID: 28654138 RESULT

• Joseph TT, Gal JS, DeMaria S Jr, Lin HM, Levine AI, Hyman JB. A Retrospective Study of Success, Failure, and Time Needed to Perform Awake Intubation. Anesthesiology. 2016 Jul;125(1):105-14. doi: 10.1097/ALN.0000000000001140.

  PMID: 27111535 RESULT

• Law JA, Morris IR, Brousseau PA, de la Ronde S, Milne AD. The incidence, success rate, and complications of awake tracheal intubation in 1,554 patients over 12 years: an historical cohort study. Can J Anaesth. 2015 Jul;62(7):736-44. doi: 10.1007/s12630-015-0387-y. Epub 2015 Apr 24.

  PMID: 25907462 RESULT

• Alhomary M, Ramadan E, Curran E, Walsh SR. Videolaryngoscopy vs. fibreoptic bronchoscopy for awake tracheal intubation: a systematic review and meta-analysis. Anaesthesia. 2018 Sep;73(9):1151-1161. doi: 10.1111/anae.14299. Epub 2018 Apr 17.

  PMID: 29687891 RESULT

• Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.

  PMID: 21447488 RESULT

• Weinger MB, Vredenburgh AG, Schumann CM, Macario A, Williams KJ, Kalsher MJ, Smith B, Truong PC, Kim A. Quantitative description of the workload associated with airway management procedures. J Clin Anesth. 2000 Jun;12(4):273-82. doi: 10.1016/s0952-8180(00)00152-5.

  PMID: 10960198 RESULT

• 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 RESULT

• He XY, Cao JP, He Q, Shi XY. Dexmedetomidine for the management of awake fibreoptic intubation. Cochrane Database Syst Rev. 2014 Jan 19;2014(1):CD009798. doi: 10.1002/14651858.CD009798.pub2.

  PMID: 24442817 RESULT

• Moller IW, Krantz T, Wandall E, Kehlet H. Effect of alfentanil anaesthesia on the adrenocortical and hyperglycaemic response to abdominal surgery. Br J Anaesth. 1985 Jun;57(6):591-4. doi: 10.1093/bja/57.6.591.

  PMID: 3924084 RESULT

• Lin YJ, Wang YC, Huang HH, Huang CH, Liao MX, Lin PL. Target-controlled propofol infusion with or without bispectral index monitoring of sedation during advanced gastrointestinal endoscopy. J Gastroenterol Hepatol. 2020 Jul;35(7):1189-1195. doi: 10.1111/jgh.14943. Epub 2019 Dec 6.

  PMID: 31802534 RESULT

• Chiang MH, Wu SC, You CH, Wu KL, Chiu YC, Ma CW, Kao CW, Lin KC, Chen KH, Wang PC, Chou AK. Target-controlled infusion vs. manually controlled infusion of propofol with alfentanil for bidirectional endoscopy: a randomized controlled trial. Endoscopy. 2013 Nov;45(11):907-14. doi: 10.1055/s-0033-1344645. Epub 2013 Oct 28.

  PMID: 24165817 RESULT

Study Officials

• Qiaoqiao Xu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiaoqiao Xu

CONTACT

+8618771006963; qiaoqiaoxu@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and deputy chief physician

Model Details: crisscross

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 7, 2023
• Study Start: April 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study and publication of the article

Locations

CN (1)