AnesthesiaNCT04658173
Efficacy and Safety Profile of Remimazolam-alfentanil Combination for ERCP Sedation
A study testing remimazolam-alfentanil combination and propofol-alfentanil combination in people with Anesthesia, run by Tianjin Nankai Hospital at 2 sites in China.
Trial summary
Moderate to deep levels of sedation and analgesia are required for ERCP. Propofol-based sedation is simple, easy to use, and effective, but is not without cardiovascular and respiratory adverse effects. The combination of remimazolam and alfentanil has shown promising results for sedation in other similar scenarios. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- remimazolam-alfentanil combination and propofol-alfentanil combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 22 Dec 2020to 1 Oct 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is between 18 and 85 years
- ASA I-III levels;
- Patients undergone elective ERCP surgery, non-intubation patients;
Who cannot join
- Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- BMI<18 or BMI>30;
- Abnormal renal function ;
- Previous abnormal surgical anesthesia recovery history;
- Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
- Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
Show all 12Show fewer
- Expected difficult intubation ;
- Opioids allergy history;
- Take monoamine oxidase inhibitor or antidepressant within 15 days;
- Pregnant or parturient women;
- Involved in other drug trials within three months;
- Patients who can not communicate well with the researcher
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300100
Jianbo Yu, MD, 86-022-27435008, nkyyll@126.com
86-022-27435008, nkyyll@126.com
- Recruiting
Tianjin NanKai hospital
Tianjin, Tianjin Municipality
Jianbo Yu, MD,PhD, 022-27435873, yujianbo11@126.com
About this study
Official title: A Randomized, Controlled Trial to Compare the Efficacy and Safety Profile of a Remimazolam-alfentanil Combination With a Propofol-alfentanil Combination for ERCP
Moderate to deep levels of sedation and analgesia are required for ERCP. Propofol-based sedation is simple, easy to use, and effective, but is not without cardiovascular and respiratory adverse effects. The combination of remimazolam and alfentanil has shown promising results for sedation in other similar scenarios. The aim of this study was to compare the efficacy and safety of a standard propofol-alfentanil regimen with a remimazolam-alfentanil combination.
Read the detailed description
What is already known about this topic is that propofol-based sedation techniques are effective for ERCP procedures but are not without cardiovascular and respiratory adverse effects.
- Title:A randomized, controlled trial to compare the efficacy and safety profile of a remimazolam-alfentanil combination with a propofol-alfentanil combination for ERCP.
- Research center: Single center.
- The Design of the study: Randomized, double-blind, controlled study.
- The population of the study: Age is between 18 and 85 years; ASA I-III levels; Patients undergone elective ERCP surgery, non-intubation patients;
- Sample size: Based on Akhondzadeh R et al. research, propofol based sedation resulted in 43% patients present oxygen desaturation, and assuming a 15% reduction in hypoxic events in remimazolam group. From this, we have estimated that oxygen desaturation rate will be 43% in the propofol group and 28 % in the remimazolam group. We have estimated that, with a sample size of 207 patients, the study will have 80% power to detect a significant difference using the log-rank test. We have estimated that the rate of dropout or withdrawal will be approximately 20%, and thus we plan to enroll 259 patients each group
- Interventions: Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed. Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope,propofol 0.5mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed.
- Outcome： Primary outcome： The occurrence of hypoxia, defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90% of any duration. Secondary outcome： Number of events of hypoxia, defined as desaturation < 90%. The mean number of events during the procedure will be compared between the two groups. Lowest recorded SpO2 during the procedure. Requirement of minor airway manoeuvres: jaw lift/jaw thrust, nasopharyngeal airway insertion. Requirement of major airway manoeuvres: bag mask ventilation, endotracheal intubation. Total alfentanyl dose. The mean values (the doses in micrograms) during the procedure will be compared between the two groups. Requirement of antispasmodic agent. Proportion of patients requiring this medication will be compared between the two groups. Endoscope re-insertion rate. Rescued sedation: drugs dose. Total duration of procedure. Duration under sedation/anaesthesia. Successful completion of the procedure: Yes/No. Proportion of patients fulfilling this criterion will be compared between the two groups. Sensation of abdominal bloating: Y/N. Proportion of patients experiencing this adverse event will be compared between the two groups. Patients' satisfaction score on leaving recovery: 5 points numerical rating scale: Very satisfied (5), somewhat satisfied (4), neither satisfied nor dissatisfied (3), somewhat dissatisfied (2), very dissatisfied (1). Proportion of patients at a particular threshold will be compared between the two groups. The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible. QOR-15. Recovery time :The time to recovery based on Modified Aldrete score was noted every 5 minutes, starting from the time of endoscope removal . A score of 9 was considered as recovery and the patient was discharged to the ward.The estimated duration of the study:2-3 years. If the procure is expected more than 1 hour, the arterial blood gas (ABG) will be detected before and after the ERCP, and the serum Aβ1-40 will be also determined by the commercial kits.
- Adverse events: Incidence of hypertention, hypotension，tachycardia , bradycardia，nausea，vomiting, POD, Sensation of abdominal bloating, The dosage of urapidil, ephedrine, atropine and esmolol during the observation period
- Safety consideration: ECG, HR, MAP, respiratory rate was monitored.
- Statistical analysis Mean and standard deviation values will be estimated for continuous outcomes while frequency and percentage will be computed for binary outcomes. 95% confidence intervals around the point estimate will be calculated where appropriate for the primary and secondary outcomes. Descriptive statistics will be used to present the results. P < 0.05 will be considered significant. Analyses will be intention-to-treat from randomisation. All randomised cases will be included in the analyses, regardless of missing data. As the data capture is only limited to a few hours after the intervention and the investigators are directly involved in the conduct of the study, we anticipate very few missing data. A subgroup analyses will be attempted (if feasible)
- Conditions
- Anesthesia
- Being tested
- remimazolam-alfentanil combination, propofol-alfentanil combination
- Keywords
- ERCP, Propofol, Remimazolam, Alfentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam-alfentanil combinationDrug
Also called RA Combination
Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
propofol-alfentanil combinationDrug
Also called PA combination
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs，and alfentanil 5ug/kg when additional analgesia is needed
| Study group | Role | What they receive |
|---|---|---|
| remimazolam-alfentanil combination | Experimental | Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed Receives: Drug: remimazolam-alfentanil combination |
| propofol-alfentanil combination | Active comparator | Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed Receives: Drug: propofol-alfentanil combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of hypoxia
defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90% of any duration.
Measured: 1 day
Secondary outcomes (16)
Number of events of hypoxia, defined as desaturation < 90%.
The mean number of events during the procedure will be compared between the two groups
Measured: 1 day
Lowest recorded SpO2 during the procedure
the lowest SpO2 during the procedure
Measured: 1 day
the number of requirement for minor airway manoeuvres
such as jaw lift/jaw thrust, nasopharyngeal airway insertion.
Measured: 1 day
the number of requirement for major airway manoeuvres
such as bag mask ventilation, endotracheal intubation.
Measured: 1 day
Total alfentanyl dose
The mean values during the procedure will be compared between the two groups
Measured: 1 day
Requirement of antispasmodic agent
Proportion of patients requiring this medication will be compared between the two groups
Measured: 1 day
Endoscope re-insertion rate
Endoscope reinsertion
Measured: 1 day
Rescued sedation:
drugs dose
Measured: 1 day
Total duration of procedure
the duration of ERCP
Measured: 1 day
Duration under sedation/anaesthesia
Total anesthesia duration
Measured: 1day
Successful completion of the procedure
Yes/No. Proportion of patients fulfilling this criterion will be compared between the two groups
Measured: 1 day
Sensation of abdominal bloating
Y/N. Proportion of patients experiencing this adverse event will be compared between the two groups
Measured: 1-3 days
Patients' satisfaction score on leaving recovery
5 points numerical rating scale: Very satisfied (5), somewhat satisfied (4), neither satisfied nor dissatisfied (3), somewhat dissatisfied (2), very dissatisfied (1). Proportion of patients at a particular threshold will be compared between the two groups
Measured: 1-3 days
The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible
The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible
Measured: 1 days
quality of recovery score-15
The quality of recovery score (QOR)-15 questionnaire
Measured: 1-3 days
Recovery time
The time to recovery based on Modified Aldrete score was noted every 5 minutes, starting from the time of endoscope removal 9. A score of 9 was considered as recovery and the patient was discharged to the ward.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start22 Dec 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Yu, Tianjin Nankai Hospital
- Investigators
- Jianbo Yu, MD, Principal investigator, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658173
- Sponsor's protocol ID
- NKYY_YXKT_IRB_2020_063_01
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2020
- Last updated
- 20 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akhondzadeh R, Ghomeishi A, Nesioonpour S, Nourizade S. A comparison between the effects of propofol-fentanyl with propofol-ketamine for sedation in patients undergoing endoscopic retrograde cholangiopancreatography outside the operating room. Biomed J. 2016 Apr;39(2):145-9. doi: 10.1016/j.bj.2015.11.002. Epub 2016 Jun 21.
PubMed 27372170Mazanikov M, Udd M, Kylanpaa L, Mustonen H, Lindstrom O, Farkkila M, Halttunen J, Poyhia R. A randomized comparison of target-controlled propofol infusion and patient-controlled sedation during ERCP. Endoscopy. 2013 Nov;45(11):915-9. doi: 10.1055/s-0033-1344712. Epub 2013 Oct 8.
PubMed 24104763Eberl S, Koers L, van Hooft J, de Jong E, Hermanides J, Hollmann MW, Preckel B. The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial. Eur J Anaesthesiol. 2020 May;37(5):394-401. doi: 10.1097/EJA.0000000000001134.
PubMed 31860599Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
PubMed 29723512Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.
PubMed 30292760Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
PubMed 22190555Goyal R, Hasnain S, Mittal S, Shreevastava S. A randomized, controlled trial to compare the efficacy and safety profile of a dexmedetomidine-ketamine combination with a propofol-fentanyl combination for ERCP. Gastrointest Endosc. 2016 May;83(5):928-33. doi: 10.1016/j.gie.2015.08.077. Epub 2015 Sep 11.
PubMed 26364968Thiruvenkatarajan V, Dharmalingam A, Arenas G, Wahba M, Steiner R, Kadam VR, Tran A, Currie J, Van Wijk R, Quail A, Ludbrook G. High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial. Trials. 2020 May 29;21(1):444. doi: 10.1186/s13063-020-04378-z.
PubMed 32471494Eberl S, Koers L, van Hooft JE, de Jong E, Schneider T, Hollmann MW, Preckel B. Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial. Trials. 2017 Oct 11;18(1):472. doi: 10.1186/s13063-017-2197-8.
PubMed 29020995
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Compare the Efficacy and Safety Profile of a Remimazolam-alfentanil Combination With a Propofol-alfentanil Combination for ERCP
- ClinicalTrials.gov ID
- NCT04658173
- Acronym / sponsor ID
- NKYY_YXKT_IRB_2020_063_01
- Conditions
- Anesthesia
- Keywords
- ERCP, Propofol, Remimazolam, Alfentanil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Dec 2020 (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.
Moderate to deep levels of sedation and analgesia are required for ERCP. Propofol-based sedation is simple, easy to use, and effective, but is not without cardiovascular and respiratory adverse effects. The combination of remimazolam and alfentanil has shown promising results for sedation in other similar scenarios. The aim of this study was to compare the efficacy and safety of a standard propofol-alfentanil regimen with a remimazolam-alfentanil combination.
Detailed description
What is already known about this topic is that propofol-based sedation techniques are effective for ERCP procedures but are not without cardiovascular and respiratory adverse effects.
- Title:A randomized, controlled trial to compare the efficacy and safety profile of a remimazolam-alfentanil combination with a propofol-alfentanil combination for ERCP.
- Research center: Single center.
- The Design of the study: Randomized, double-blind, controlled study.
- The population of the study: Age is between 18 and 85 years; ASA I-III levels; Patients undergone elective ERCP surgery, non-intubation patients;
- Sample size: Based on Akhondzadeh R et al. research, propofol based sedation resulted in 43% patients present oxygen desaturation, and assuming a 15% reduction in hypoxic events in remimazolam group. From this, we have estimated that oxygen desaturation rate will be 43% in the propofol group and 28 % in the remimazolam group. We have estimated that, with a sample size of 207 patients, the study will have 80% power to detect a significant difference using the log-rank test. We have estimated that the rate of dropout or withdrawal will be approximately 20%, and thus we plan to enroll 259 patients each group
- Interventions: Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed. Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope,propofol 0.5mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed.
- Outcome： Primary outcome： The occurrence of hypoxia, defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90% of any duration. Secondary outcome： Number of events of hypoxia, defined as desaturation < 90%. The mean number of events during the procedure will be compared between the two groups. Lowest recorded SpO2 during the procedure. Requirement of minor airway manoeuvres: jaw lift/jaw thrust, nasopharyngeal airway insertion. Requirement of major airway manoeuvres: bag mask ventilation, endotracheal intubation. Total alfentanyl dose. The mean values (the doses in micrograms) during the procedure will be compared between the two groups. Requirement of antispasmodic agent. Proportion of patients requiring this medication will be compared between the two groups. Endoscope re-insertion rate. Rescued sedation: drugs dose. Total duration of procedure. Duration under sedation/anaesthesia. Successful completion of the procedure: Yes/No. Proportion of patients fulfilling this criterion will be compared between the two groups. Sensation of abdominal bloating: Y/N. Proportion of patients experiencing this adverse event will be compared between the two groups. Patients' satisfaction score on leaving recovery: 5 points numerical rating scale: Very satisfied (5), somewhat satisfied (4), neither satisfied nor dissatisfied (3), somewhat dissatisfied (2), very dissatisfied (1). Proportion of patients at a particular threshold will be compared between the two groups. The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible. QOR-15. Recovery time :The time to recovery based on Modified Aldrete score was noted every 5 minutes, starting from the time of endoscope removal . A score of 9 was considered as recovery and the patient was discharged to the ward.The estimated duration of the study:2-3 years. If the procure is expected more than 1 hour, the arterial blood gas (ABG) will be detected before and after the ERCP, and the serum Aβ1-40 will be also determined by the commercial kits.
- Adverse events: Incidence of hypertention, hypotension，tachycardia , bradycardia，nausea，vomiting, POD, Sensation of abdominal bloating, The dosage of urapidil, ephedrine, atropine and esmolol during the observation period
- Safety consideration: ECG, HR, MAP, respiratory rate was monitored.
- Statistical analysis Mean and standard deviation values will be estimated for continuous outcomes while frequency and percentage will be computed for binary outcomes. 95% confidence intervals around the point estimate will be calculated where appropriate for the primary and secondary outcomes. Descriptive statistics will be used to present the results. P < 0.05 will be considered significant. Analyses will be intention-to-treat from randomisation. All randomised cases will be included in the analyses, regardless of missing data. As the data capture is only limited to a few hours after the intervention and the investigators are directly involved in the conduct of the study, we anticipate very few missing data. A subgroup analyses will be attempted (if feasible)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam-alfentanil combination | Experimental | Drug: remimazolam-alfentanil combinationGroup remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed |
| propofol-alfentanil combination | Active comparator | Drug: propofol-alfentanil combinationGroup propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age is between 18 and 85 years
- ASA I-III levels;
- Patients undergone elective ERCP surgery, non-intubation patients;
Key exclusion criteria (12 listed)
- Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- BMI<18 or BMI>30;
- Abnormal renal function ;
- Previous abnormal surgical anesthesia recovery history;
- Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
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 |
|---|---|---|
| remimazolam-alfentanil combinationAlso: RA CombinationGroup remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed | Drug | remimazolam-alfentanil combination |
| propofol-alfentanil combinationAlso: PA combinationGroup propofol-alfentanil combination received 10 µg/kg alfentanil and 1 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs，and alfentanil 5ug/kg when additional analgesia is needed | Drug | propofol-alfentanil combination |
Primary outcome
The number of hypoxia
Time frame: 1 day
defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90% of any duration.
16 secondary outcomes
Number of events of hypoxia, defined as desaturation < 90%.
Time frame: 1 day
Lowest recorded SpO2 during the procedure
Time frame: 1 day
the number of requirement for minor airway manoeuvres
Time frame: 1 day
the number of requirement for major airway manoeuvres
Time frame: 1 day
Total alfentanyl dose
Time frame: 1 day
Requirement of antispasmodic agent
Time frame: 1 day
Endoscope re-insertion rate
Time frame: 1 day
Rescued sedation:
Time frame: 1 day
Total duration of procedure
Time frame: 1 day
Duration under sedation/anaesthesia
Time frame: 1day
Successful completion of the procedure
Time frame: 1 day
Sensation of abdominal bloating
Time frame: 1-3 days
Patients' satisfaction score on leaving recovery
Time frame: 1-3 days
The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible
Time frame: 1 days
quality of recovery score-15
Time frame: 1-3 days
Recovery time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Results publication: PubMed 27372170Akhondzadeh R, Ghomeishi A, Nesioonpour S, Nourizade S. A comparison between the effects of propofol-fentanyl with propofol-ketamine for sedation in patients undergoing endoscopic retrograde cholangiopancreatography outside the operating room. Biomed J. 2016 Apr;39(2):145-9. doi: 10.1016/j.bj.2015.11.002. Epub 2016 Jun 21.
- Results publication: PubMed 24104763Mazanikov M, Udd M, Kylanpaa L, Mustonen H, Lindstrom O, Farkkila M, Halttunen J, Poyhia R. A randomized comparison of target-controlled propofol infusion and patient-controlled sedation during ERCP. Endoscopy. 2013 Nov;45(11):915-9. doi: 10.1055/s-0033-1344712. Epub 2013 Oct 8.
- Results publication: PubMed 31860599Eberl S, Koers L, van Hooft J, de Jong E, Hermanides J, Hollmann MW, Preckel B. The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial. Eur J Anaesthesiol. 2020 May;37(5):394-401. doi: 10.1097/EJA.0000000000001134.
- Results publication: PubMed 29723512Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
- Results publication: PubMed 30292760Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.
- Results publication: PubMed 22190555Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
- Results publication: PubMed 26364968Goyal R, Hasnain S, Mittal S, Shreevastava S. A randomized, controlled trial to compare the efficacy and safety profile of a dexmedetomidine-ketamine combination with a propofol-fentanyl combination for ERCP. Gastrointest Endosc. 2016 May;83(5):928-33. doi: 10.1016/j.gie.2015.08.077. Epub 2015 Sep 11.
- Results publication: PubMed 32471494Thiruvenkatarajan V, Dharmalingam A, Arenas G, Wahba M, Steiner R, Kadam VR, Tran A, Currie J, Van Wijk R, Quail A, Ludbrook G. High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial. Trials. 2020 May 29;21(1):444. doi: 10.1186/s13063-020-04378-z.
- Results publication: PubMed 29020995Eberl S, Koers L, van Hooft JE, de Jong E, Schneider T, Hollmann MW, Preckel B. Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial. Trials. 2017 Oct 11;18(1):472. doi: 10.1186/s13063-017-2197-8.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Jianbo Yu, MD principal investigator
Tianjin Nankai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam-alfentanil combination and propofol-alfentanil combination in people with Anesthesia, run by Tianjin Nankai Hospital at 2 sites 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 3 inclusion and 12 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 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jianbo Yu, MD (86-22-27435873, yujianbo11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of hypoxia (time frame: 1 day). 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 NCT04658173, which also lists 9 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 20 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.