Clinical trial NCT04656964: Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients
Gastrointestinal Endoscopy
Midazolam
Remimazolam
Keywords: Remimazolam tosilate
Midazolam
postsedation effect
postsedation safety
cognition function
patients' satisfaction
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Emergency General Hospital
name: Fenyang Hospital Affiliated to Shanxi Medical University
First posted: 2020-12-07
Enrollment: 353
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Recovery time after operation
timeFrame: Day 0
Secondary outcomes:
measure: Supine heart rate[HR]
timeFrame: Day 0
measure: Modified Observer's Assessment of Alertness/Sedation[MOAA/S]
timeFrame: Day 0
measure: Visual analogue scale (VAS)
timeFrame: Day 0
measure: Post-anesthesia discharge score (PADS)
timeFrame: Record within 2 hours ，no more than 6 hours
measure: Perioperative anesthesia effect
timeFrame: Day 0
measure: Drug dosages
timeFrame: Day 0
measure: Simple Intelligence Assessment Scale (mini-cog)
timeFrame: Every 4 hours, up to 1 week.
measure: Patient overall satisfaction and surgeon satisfaction score
timeFrame: Day 0
measure: Systolic, diastolic, and mean blood pressure [MBP]
timeFrame: Day 0
measure: Assessment of pulse oximetry measurements[SpO2]
timeFrame: Day 0
measure: Respiration rate[RR]
timeFrame: Day 0
measure: End-tidal carbon dioxide [EtCO2]
timeFrame: Day 0
measure: Rate of coughing and vomiting
timeFrame: Within 24 hours
measure: Level of hypoxia
timeFrame: Within 24 hours
measure: Respiratory depression
timeFrame: Within 24 hours
measure: Abdominal pain and nausea
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: