Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy

Elderly Patients Clinical Trial

Official title:

The Safety and Effectiveness of Remimazolam Tosilate Versus Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy: A Multicenter ,Prospective, Double-Blinded, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656964
• Other study ID #: 2020PHB249-01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Description:

Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;

2. Age 60 to 75 ;

3. ASA physical status score of I, II or III;

4. A body mass index (BMI) of 19 to 28 kg/m2;

5. Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation =95%

Exclusion Criteria:

1. Those who are refused to be included;

2. Those who are allergic to the drugs used in this study;

3. Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);

4. Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;

5. Renal failure or liver cirrhosis;

6. Severe lung infection or upper respiratory tract infection;

7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;

8. Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;

Related Conditions & MeSH terms

• Elderly Patients
• Gastrointestinal Endoscopy
• Midazolam
• Remimazolam

Intervention

Drug:
• remimazolam tosilate group
Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).
• Midazolam group
Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).

Locations

Country	Name	City	State
China	Peking University People's Hospital	Peking	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Emergency General Hospital, Fenyang Hospital Affiliated to Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time after operation	First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.	Day 0
Secondary	Supine heart rate[HR]	Supine heart rate[HR] in (times)	Day 0
Secondary	Modified Observer's Assessment of Alertness/Sedation[MOAA/S]	MOAA/S score ranges from 0 to 5 points, 0 point means patients do not respond to noxious stimulation; 5 point means patients responds readily to name spoken in normal tone. When the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] =4 that patients are sufficiently sedated.	Day 0
Secondary	Visual analogue scale (VAS)	The visual analogue scale (VAS) score ranges from 0 to 10 points (0mm means patients feel no pain, 100mm means patients feel the most severe pain imaginable)	Day 0
Secondary	Post-anesthesia discharge score (PADS)	Post-anesthesia discharge score PADS score ranges from 0 to 10 points. only when the PADS score=9 that will the patients leave the post-anesthesia care unit(PACU).	Record within 2 hours ,no more than 6 hours
Secondary	Perioperative anesthesia effect	Induction time(from the drug administration to the start of endoscopy insertion); procedure time(from the endoscopy insertion to the end of procedure);PACU last time(from the entry to PACU to the PADS score=9).	Day 0
Secondary	Drug dosages	The total single dosage of midazolam, propofol, remifentanil and remimazolam tosilate.	Day 0
Secondary	Simple Intelligence Assessment Scale (mini-cog)	Ask the subjects to listen carefully and memorize 3 unrelated words, and then repeat (Apple, Watch, Coin); Ask the subjects to draw the shape of the clock on a blank sheet of paper, and give the subject a time to mark it on the clock (the CDT of the clock drawing test is correct; it can correctly indicate the sequence of the digits and display the given Fixed time); Ask the subject to say the 3 words given previously.	Every 4 hours, up to 1 week.
Secondary	Patient overall satisfaction and surgeon satisfaction score	The patient's overall satisfaction score and surgeon satisfaction score were evaluated by 1-10 points (1mm=completely dissatisfied, 100mm=completely satisfied).	Day 0
Secondary	Systolic, diastolic, and mean blood pressure [MBP]	Systolic, diastolic, and mean blood pressure [MBP] in(mmHg)	Day 0
Secondary	Assessment of pulse oximetry measurements[SpO2]	Assessment of pulse oximetry measurements[SpO2]in(%)	Day 0
Secondary	Respiration rate[RR]	Respiration rate[RR] in (times)	Day 0
Secondary	End-tidal carbon dioxide [EtCO2]	End-tidal carbon dioxide [EtCO2] in (%)	Day 0
Secondary	Rate of coughing and vomiting	Rate of coughing and vomiting in(%)	Within 24 hours
Secondary	Level of hypoxia	Oxygen saturation <90% for more than 1 minute ,that share a common Unit of Measure in(%)	Within 24 hours
Secondary	Respiratory depression	Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in(times)	Within 24 hours
Secondary	Abdominal pain and nausea	Abdominal pain and nausea in (%)	Within 24 hours