Hemodynamics Instability, Hysteroscopic Surgery, Propofol, Remimazolam, Respiratory Insufficiency
Conditions
Brief summary
The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery
Detailed description
* 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. ⑥ 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. ⑩ 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.
Interventions
DRUGPropofol
Propofol infusion with remifentanil
DRUGRemimazolam
Remimazolam infusion with remifentanil
Sponsors
DongGuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Patients will be enrolled to one of the two drug groups with randomization.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA PS 1-2 * Elective hysteroscopic surgery under monitored anesthesia care * No drug abuse history
Exclusion criteria
* BMI \> 30 kg/m2 * Hepatic or renal insufficiency * Alcohol abuse * Respiratory, hemodynamic compromise, or diseases * History of general/regional anesthesia during the last month * A patient who is taking sedatives or analgesics * Under the investigator's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory insufficiency before surgery | From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes) | Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96% |
| Respiratory insufficiency during surgery | From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes) | Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes | \< 90 mmHg during the Monitored Anesthetic Care |
| Bradycardia | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes | Heart rate \< 50/min during the Monitored Anesthetic Care |
| Tachycardia | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes | Heart rate \> 100/min during the Monitored Anesthetic Care |
| Pain on injection | Just after the beginning of drug infusion | Patients will answer just after drug infusion begins (Yes or No) |
| Patient satisfaction with Monitored Anesthetic Care | Just before leaving the recovery room | 4-point rating scale on the Satisfaction with MAC (4: Fully satisfied, 3: Partially satisfied, 2: Partially unsatisfied, 1: Totally unsatisfied) |
| Postoperative Nausea/Vomiting (PONV) | During staying at the recovery room (up to 60 minutes) | Patients are asked to answer yes/no on PONV, just before leaving the recovery room. |
| Maximum ETCO2 | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes | ETCO2 will be measured every single respiration in the nasal cavity |
| Hypertension | Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes | \> 140 mmHg during Monitored Anesthetic Care (MAC) |
Countries
South Korea
Outcome results
None listed