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

NCT04656964 | Completed

• 1 other identifier: 2020PHB249-01
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Patients; Gastrointestinal Endoscopy; Midazolam; Remimazolam

Keywords

Remimazolam tosilate; Midazolam; postsedation effect; postsedation safety; cognition function; patients' satisfaction

Outcome Measures

Primary Outcomes (1)

• Recovery time after operation

  First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.

  Day 0

Secondary Outcomes (16)

• Supine heart rate[HR]

  Day 0

• Modified Observer's Assessment of Alertness/Sedation[MOAA/S]

  Day 0

• Visual analogue scale (VAS)

  Day 0

• Post-anesthesia discharge score (PADS)

  Record within 2 hours ，no more than 6 hours

• Perioperative anesthesia effect

  Day 0

Study Arms (2)

Remimazolam Tosilate group

EXPERIMENTAL

Patients received remimazolam tosilate to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation.

Drug: remimazolam tosilate group

Midazolam group

ACTIVE COMPARATOR

Patients received midazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation.

Drug: Midazolam group

Interventions

remimazolam tosilate group DRUG

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).

Remimazolam Tosilate group

Midazolam group DRUG

Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).

Midazolam group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;
• Age 60 to 75 ;
• ASA physical status score of I, II or III;
• A body mass index (BMI) of 19 to 28 kg/m2;
• Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%

You may not qualify if:

• Those who are refused to be included;
• Those who are allergic to the drugs used in this study;
• Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
• Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
• Renal failure or liver cirrhosis;
• Severe lung infection or upper respiratory tract infection;
• Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;
• Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Emergency General Hospital: collaborator
• Fenyang Hospital Affiliated to Shanxi Medical University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100049, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesiology department

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: December 7, 2020
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)