RemimazolamNCT06026566
Compatible Effect of Remimazolam Besylate Combined With Afentanil for ATI
A study testing Dos of Afentanil 20, Dos of Afentanil 30 and Dos of Afentanil 40 in people with Remimazolam and Awake Endotracheal Intubation, run by Tongji Hospital at 1 site in China.
Trial summary
1. To study the pharmacokinetics between remimazolam besylate and alfentanil; 2. To determine the optimal dosage of the two drugs in awake endotracheal intubation; 3. To provide clinical guidance for awake endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Remimazolam, Awake Endotracheal Intubation
- What is being tested?
- Dos of Afentanil 20, Dos of Afentanil 30 and Dos of Afentanil 40
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Wuhan, Hubei, 430030
Qiaoqiao Xu, +8618771006963, qiaoqiaoxu@aliyun.com
About this study
Official title: Compatible Dose Study and Effect Observation of Remimazolam Besylate Combined With Afentanil for Awake Endotracheal Intubation
- To study the pharmacokinetics between remimazolam besylate and alfentanil;
- To determine the optimal dosage of the two drugs in awake endotracheal intubation;
- To provide clinical guidance for awake endotracheal intubation.
Read the detailed description
Tracheal intubation is the most effective and reliable method to establish artificial airway, which provides the best conditions for relieving airway obstruction, ensuring airway patency, removing respiratory secretions, preventing aspiration, assisting or controlling breathing, etc. Difficult airway management strategies must be adopted when patients are predicted to have difficulties in mask ventilation, supraglottic airway device (SAD) placement, or endotracheal intubation and front-of-neck airway (FONA) establishment. Awake tracheal intubation (ATI) is one of the important methods.
ATI refers to tracheal intubation while the patient is awake and breathing spontaneously, most commonly by flexible bronchoscopy (FB) or video laryngoscopy (VL), which allows for airway control prior to induction of general anesthesia. Thus, the potential risks and consequences of difficulty in establishing the airway after anesthesia induction are avoided. The safety of ATI is reflected in the guarantee of spontaneous breathing and intrinsic airway tension of patients before tracheal tube insertion. The failure rate of ATI is only 1-2%, and it rarely requires airway first aid or causes patient death.
ATI is currently the safest technique for dealing with difficult airways, but it accounts for only 0.2% of all tracheal intubation types in the UK. The reason is that ATI operators may be under great physical, mental, and psychological stress, which may lead to poor performance and increase the risk of complications, including failure. In addition, mechanical stimulation of the airway in the awake state can cause coughing, nausea, restlessness and other reactions to tracheal intubation, resulting in adverse consequences. Therefore, before the effective implementation of ATI, anesthesiologists often choose to combine small doses of analgesic and sedative drugs to achieve the minimum degree of sedation effect, so as to reduce the anxiety and discomfort of patients and improve the tolerance of patients.
Studies have shown that drugs such as fentanyl, remifentanil, midazolam, propofol and dexmedetomidine can be used to assist ATI to improve patient satisfaction and reduce the risk of excessive sedation and airway obstruction. However, these drugs have different degrees of cardiovascular or respiratory adverse reactions, especially when used in large doses, which increases the risk of hypoxemia, hypotension or bradycardia. ATI guidelines suggest that excessive sedation is very dangerous for some patients, and it is recommended to use it with caution, and a minimum degree of reversible sedation is preferred. Therefore, how to ensure good sedation and analgesia and maintain normal spontaneous breathing is worthy of further study.
Remimazolam besylate is a new type of benzodiazepine, which is an ultra-short-acting sedative/anesthetic drug. The mechanism is that by binding to benzodiazepine receptors, it specifically acts on GABAA receptors, enhances GABAA receptor activity, and selectively promotes extracellular chloride ions into cells, leading to hyperpolarization of cell membrane resting potential and decreased excitability, thus inhibiting neuronal electrical activity and producing sedative effect. And this effect can be specifically antagonized by flumazenil. As an important member of opioid receptor agonist, 30s of alfentanil exerts its drug effect, and its safety is far better than that of morphine. Alfentanil does not cause severe respiratory depression in the therapeutic dose range, and can reduce the use of sedative drugs when used in combination. In gastrointestinal endoscopy, hysteroscopy, fiberoptic bronchoscopy and other procedures with spontaneous breathing, alfentanil alone or in combination with benzodiazepines shows mild respiratory depression and high safety.
The purpose of this study is to study the pharmacokinetics between remimazolam besylate and alfentanil hydrochloride by response surface analysis, to determine the standard drug concentration under spontaneous breathing, and to observe the clinical effect of awake tracheal intubation under this concentration dose, to explore the best compatible dose range of the two drugs, in order to provide a reference for clinical application in patients with difficult airway.
- Conditions
- Remimazolam, Awake Endotracheal Intubation
- Being tested
- Dos of Afentanil 20, Dos of Afentanil 30, Dos of Afentanil 40, Dos of Afentanil 50, Dos of Afentanil 60
- Keywords
- Remimazolam, Awake Endotracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dos of Afentanil 20Drug
Also called Afentanil 20
the dosage of Afentanil is 20 ng/ml for TCI
Dos of Afentanil 30Drug
Also called Afentanil 30
the dosage of Afentanil is 30 ng/ml for TCI
Dos of Afentanil 40Drug
Also called Afentanil 40
the dosage of Afentanil is 40 ng/ml for TCI
Dos of Afentanil 50Drug
Also called Afentanil 50
the dosage of Afentanil is 50 ng/ml for TCI
Dos of Afentanil 60Drug
Also called Afentanil 60
the dosage of Afentanil is 60 ng/ml for TCI
Dos of Afentanil 70Drug
Also called Afentanil 70
the dosage of Afentanil is 70 ng/ml for TCI
Dos of Afentanil 80Drug
Also called Afentanil 80
the dosage of Afentanil is 80 ng/ml for TCI
Dos of Afentanil 90Drug
Also called Afentanil 90
the dosage of Afentanil is 90 ng/ml for TCI
Dos of Afentanil 100Drug
Also called Afentanil 100
the dosage of Afentanil is 100 ng/ml for TCI
| Study group | Role | What they receive |
|---|---|---|
| Dos of R 0.1 | Experimental | The dosage of Remimazolam Besylate is 0.1 mg/kg Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate
RR≤8bpm means respiratory rate decreased after the use of Remimazolam Besylate and Afentanil.
Measured: During surgery
Tidal volume
Vt≤5ml/kg means tidal volume decreased after the use of Remimazolam Besylate and Afentanil.
Measured: During surgery
Deep breathing
Breathing hard and deep, and then PetCO2≥55mmHg mean deep breathing after the use of Remimazolam Besylate and Afentanil.
Measured: During surgery
Airway obstruction
Difficulty in ventilation means airway obstruction after the use of Remimazolam Besylate and Afentanil.
Measured: During surgery
Oxygen saturation decreased
SpO2≤94% means oxyfen saturation decreased after the use of Remimazolam Besylate and Afentanil.
Measured: During surgery
Secondary outcomes (5)
Airway status
Airway status evaluation during intubation
Measured: During surgery
Intubation response
Body movement response during intubation
Measured: During surgery
RASS score
Rass score evaluation during anesthesia induction (+4: Combative; +3: Very agitated; +2: Agitated; +1: Restless; 0: Alert and Calm; -1: Drowsy; -2: Light Sedation; -3: Moderate Sedation; -3: Moderate Sedation; -4: Deep Sedation; -5: Unarousable)
Measured: During surgery
Hemodynamic assessments
Mean arterial blood pressure (MAP) ≤50mmHg or heart rate (HR) ≤45bpm indicates that this combination of anesthetic concentrations causes circulatory depression side effects and is recorded by "1"; otherwise, it is recorded by "0".
Measured: During surgery
The satisfaction of patients and anesthesiologists
The satisfaction of patients and anesthesiologists with the anesthesia regimen was evaluated (very satisfied, satisfied, fair, dissatisfied, very dissatisfied).
Measured: Up to 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Apr 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- crisscross
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiaoqiao Xu, Tongji Hospital
- Investigators
- Qiaoqiao Xu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026566
- Sponsor's protocol ID
- TongjiHospital-Anes QQ01
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To provide clinical application reference of the pharmacokinetics between remimazolam besylate and alfentanil for awake endotracheal intubation.
Publications
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.
PubMed 23388507Ahmad 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.
PubMed 31729018Ajay 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.
PubMed 24427550Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.
PubMed 29210033El-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.
PubMed 28654138Joseph 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.
PubMed 27111535Law 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.
PubMed 25907462Alhomary 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.
PubMed 29687891Cook 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.
PubMed 21447488Weinger 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.
PubMed 10960198Johnston 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 23512191He 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.
PubMed 24442817Moller 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.
PubMed 3924084Lin 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.
PubMed 31802534Chiang 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.
PubMed 24165817
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compatible Dose Study and Effect Observation of Remimazolam Besylate Combined With Afentanil for Awake Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT06026566
- Acronym / sponsor ID
- TongjiHospital-Anes QQ01
- Conditions
- Remimazolam, Awake Endotracheal Intubation
- Keywords
- Remimazolam, Awake Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To study the pharmacokinetics between remimazolam besylate and alfentanil;
- To determine the optimal dosage of the two drugs in awake endotracheal intubation;
- To provide clinical guidance for awake endotracheal intubation.
Detailed description
Tracheal intubation is the most effective and reliable method to establish artificial airway, which provides the best conditions for relieving airway obstruction, ensuring airway patency, removing respiratory secretions, preventing aspiration, assisting or controlling breathing, etc. Difficult airway management strategies must be adopted when patients are predicted to have difficulties in mask ventilation, supraglottic airway device (SAD) placement, or endotracheal intubation and front-of-neck airway (FONA) establishment. Awake tracheal intubation (ATI) is one of the important methods.
ATI refers to tracheal intubation while the patient is awake and breathing spontaneously, most commonly by flexible bronchoscopy (FB) or video laryngoscopy (VL), which allows for airway control prior to induction of general anesthesia. Thus, the potential risks and consequences of difficulty in establishing the airway after anesthesia induction are avoided. The safety of ATI is reflected in the guarantee of spontaneous breathing and intrinsic airway tension of patients before tracheal tube insertion. The failure rate of ATI is only 1-2%, and it rarely requires airway first aid or causes patient death.
ATI is currently the safest technique for dealing with difficult airways, but it accounts for only 0.2% of all tracheal intubation types in the UK. The reason is that ATI operators may be under great physical, mental, and psychological stress, which may lead to poor performance and increase the risk of complications, including failure. In addition, mechanical stimulation of the airway in the awake state can cause coughing, nausea, restlessness and other reactions to tracheal intubation, resulting in adverse consequences. Therefore, before the effective implementation of ATI, anesthesiologists often choose to combine small doses of analgesic and sedative drugs to achieve the minimum degree of sedation effect, so as to reduce the anxiety and discomfort of patients and improve the tolerance of patients.
Studies have shown that drugs such as fentanyl, remifentanil, midazolam, propofol and dexmedetomidine can be used to assist ATI to improve patient satisfaction and reduce the risk of excessive sedation and airway obstruction. However, these drugs have different degrees of cardiovascular or respiratory adverse reactions, especially when used in large doses, which increases the risk of hypoxemia, hypotension or bradycardia. ATI guidelines suggest that excessive sedation is very dangerous for some patients, and it is recommended to use it with caution, and a minimum degree of reversible sedation is preferred. Therefore, how to ensure good sedation and analgesia and maintain normal spontaneous breathing is worthy of further study.
Remimazolam besylate is a new type of benzodiazepine, which is an ultra-short-acting sedative/anesthetic drug. The mechanism is that by binding to benzodiazepine receptors, it specifically acts on GABAA receptors, enhances GABAA receptor activity, and selectively promotes extracellular chloride ions into cells, leading to hyperpolarization of cell membrane resting potential and decreased excitability, thus inhibiting neuronal electrical activity and producing sedative effect. And this effect can be specifically antagonized by flumazenil. As an important member of opioid receptor agonist, 30s of alfentanil exerts its drug effect, and its safety is far better than that of morphine. Alfentanil does not cause severe respiratory depression in the therapeutic dose range, and can reduce the use of sedative drugs when used in combination. In gastrointestinal endoscopy, hysteroscopy, fiberoptic bronchoscopy and other procedures with spontaneous breathing, alfentanil alone or in combination with benzodiazepines shows mild respiratory depression and high safety.
The purpose of this study is to study the pharmacokinetics between remimazolam besylate and alfentanil hydrochloride by response surface analysis, to determine the standard drug concentration under spontaneous breathing, and to observe the clinical effect of awake tracheal intubation under this concentration dose, to explore the best compatible dose range of the two drugs, in order to provide a reference for clinical application in patients with difficult airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- crisscross
| Arm | Type | Receives |
|---|---|---|
| Dos of R 0.1 | Experimental | 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 100The dosage of Remimazolam Besylate is 0.1 mg/kg |
| Dos of R 0.15 | Experimental | 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 90The dosage of Remimazolam Besylate is 0.15 mg/kg |
| Dos of R 0.2 | Experimental | 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 80The dosage of Remimazolam Besylate is 0.2 mg/kg |
| Dos of R 0.25 | Experimental | 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 80The dosage of Remimazolam Besylate is 0.25 mg/kg |
| Dos of R 0.3 | Experimental | 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 70The dosage of Remimazolam Besylate is 0.3 mg/kg |
| Dos of R 0.35 | Experimental | 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 70The dosage of Remimazolam Besylate is 0.25 mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dos of Afentanil 20Also: Afentanil 20the dosage of Afentanil is 20 ng/ml for TCI | Drug | Dos of R 0.3, Dos of R 0.35 |
| Dos of Afentanil 30Also: Afentanil 30the dosage of Afentanil is 30 ng/ml for TCI | Drug | Dos of R 0.2, Dos of R 0.25, Dos of R 0.3, Dos of R 0.35 |
| Dos of Afentanil 40Also: Afentanil 40the dosage of Afentanil is 40 ng/ml for TCI | Drug | 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 50Also: Afentanil 50the dosage of Afentanil is 50 ng/ml for TCI | Drug | 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 60Also: Afentanil 60the dosage of Afentanil is 60 ng/ml for TCI | Drug | 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 70Also: Afentanil 70the dosage of Afentanil is 70 ng/ml for TCI | Drug | 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 80Also: Afentanil 80the dosage of Afentanil is 80 ng/ml for TCI | Drug | Dos of R 0.1, Dos of R 0.15, Dos of R 0.2, Dos of R 0.25 |
| Dos of Afentanil 90Also: Afentanil 90the dosage of Afentanil is 90 ng/ml for TCI | Drug | Dos of R 0.1, Dos of R 0.15 |
| Dos of Afentanil 100Also: Afentanil 100the dosage of Afentanil is 100 ng/ml for TCI | Drug | Dos of R 0.1 |
Primary outcome
Respiratory Rate
Time frame: During surgery
RR≤8bpm means respiratory rate decreased after the use of Remimazolam Besylate and Afentanil.
Tidal volume
Time frame: During surgery
Vt≤5ml/kg means tidal volume decreased after the use of Remimazolam Besylate and Afentanil.
Deep breathing
Time frame: During surgery
Breathing hard and deep, and then PetCO2≥55mmHg mean deep breathing after the use of Remimazolam Besylate and Afentanil.
Airway obstruction
Time frame: During surgery
Difficulty in ventilation means airway obstruction after the use of Remimazolam Besylate and Afentanil.
Oxygen saturation decreased
Time frame: During surgery
SpO2≤94% means oxyfen saturation decreased after the use of Remimazolam Besylate and Afentanil.
5 secondary outcomes
Airway status
Time frame: During surgery
Intubation response
Time frame: During surgery
RASS score
Time frame: During surgery
Hemodynamic assessments
Time frame: During surgery
The satisfaction of patients and anesthesiologists
Time frame: Up to 2 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 23388507Bi 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.
- Results publication: PubMed 31729018Ahmad 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.
- Results publication: PubMed 24427550Ajay 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.
- Results publication: PubMed 29210033Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.
- Results publication: PubMed 28654138El-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.
- Results publication: PubMed 27111535Joseph 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.
- Results publication: PubMed 25907462Law 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.
- Results publication: PubMed 29687891Alhomary 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.
- Results publication: PubMed 21447488Cook 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.
- Results publication: PubMed 10960198Weinger 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.
- Results publication: PubMed 23512191Johnston 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.
- Results publication: PubMed 24442817He 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.
- Individual participant dataSharing planned: Yes. To provide clinical application reference of the pharmacokinetics between remimazolam besylate and alfentanil for awake endotracheal intubation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiaoqiao Xu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dos of Afentanil 20, Dos of Afentanil 30 and Dos of Afentanil 40 in people with Remimazolam and Awake Endotracheal Intubation, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiaoqiao Xu (+8618771006963, qiaoqiaoxu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate (time frame: During surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026566, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.