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The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery
Non-invasive blood pressure, electrocardiogram, and oxygen saturation sensors are attached.
Wear an oxygen mask (5L per minute), and place the sampling line for end-tidal carbon dioxide partial pressure measurement inside the nose.
Check the randomization table to determine the drug to be administered, and prepare propofol or remimazolam accordingly.
Record the baseline values (0 min).
Start administration of Remifentanil.
â‘¥ Administer anesthesia to adjust the maintenance dose to reach a sedation level of 2 or less on the MOAA/S scale.
⑦ Adjust the remifentanil dose according to the patient's response
⑧ When the target sedation level is reached, the surgical preparation process and surgery begin, and the study variables are observed and recorded at 5-minute intervals.
⑨ Stop drug administration upon end of surgery.
â‘© After confirming proper recovery of consciousness and spontaneous breathing, leave the recovery room.
⑪ Before leaving the recovery room, check the complete recovery and investigate the patient's satisfaction with anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol group | Active Comparator | Propofol infusion with remifentanil for hysteroscopic surgery |
|
| Remimazolam group | Active Comparator | Remimazolam infusion with remifentanil for hysteroscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol infusion with remifentanil |
| |
| Remimazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory insufficiency before surgery | Respiratory rate < 9/min, Apnea > 29 s, ETCO2 > 54 mmHg, SpO2 < 96% | From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes) |
| Respiratory insufficiency during surgery | Respiratory rate < 9/min, Apnea > 29 s, ETCO2 > 54 mmHg, SpO2 < 96% | From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on injection | Patients will answer just after drug infusion begins (Yes or No) | Just after the beginning of drug infusion |
| Hypertension | > 140 mmHg during Monitored Anesthetic Care (MAC) |
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Inclusion Criteria:
Exclusion Criteria:
with gynecologic surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital | Goyang | Gyeonggido | 10326 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34144683 | Background | Zhang X, Li S, Liu J. Correction to: Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial. BMC Anesthesiol. 2021 Jun 18;21(1):173. doi: 10.1186/s12871-021-01390-x. No abstract available. | |
| 22190555 | Background | Antonik 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. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| C522201 | remimazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Patients will be enrolled to one of the two drug groups with randomization.
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Care giver will notice which drug will be given to the patients because of the color (White vs clear) and infusion doses of the drugs.
| Drug |
Remimazolam infusion with remifentanil |
|
| Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes |
| Hypotension | < 90 mmHg during the Monitored Anesthetic Care | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes |
| Bradycardia | Heart rate < 50/min during the Monitored Anesthetic Care | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes |
| Tachycardia | Heart rate > 100/min during the Monitored Anesthetic Care | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes |
| Maximum ETCO2 | ETCO2 will be measured every single respiration in the nasal cavity | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes |
| Patient satisfaction with Monitored Anesthetic Care | 4-point rating scale on the Satisfaction with MAC (4: Fully satisfied, 3: Partially satisfied, 2: Partially unsatisfied, 1: Totally unsatisfied) | Just before leaving the recovery room |
| Postoperative Nausea/Vomiting (PONV) | Patients are asked to answer yes/no on PONV, just before leaving the recovery room. | During staying at the recovery room (up to 60 minutes) |
| 22253270 | Background | Wiltshire HR, 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 II. Population pharmacokinetic and pharmacodynamic modeling and simulation. Anesth Analg. 2012 Aug;115(2):284-96. doi: 10.1213/ANE.0b013e318241f68a. Epub 2012 Jan 16. |
| 32530890 | Background | Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877. |
| 32417976 | Background | Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |