Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

NCT06777758 | Recruiting Phase 4

• 1 other identifier: KSVGH24-CT8-16
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Conditions

Postoperative Complications; Respiratory Depression; Postoperative Nausea; Vomiting; Constipation

Keywords

endoscope; Respiratory depression; Remimazolam、; Sedation; BYFAVO

Outcome Measures

Primary Outcomes (1)

• Dose change

  Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)

  Perioperatively (during upper gastrointestinal endoscopy)

Secondary Outcomes (8)

• Incidence of postoperative nausea and vomiting.

  After returning to the ward from the recovery room until before breakfast on the first postoperative day.

• Time to open eyes after stopping Propofol or Remimazolam.

  The timer starts after the anesthetic is administered.

• Use of rescue medications during surgery.

  During surgery

• Analgesic dosage in the recovery room.

  Observation period in the postoperative recovery room

• Analgesic dosage in the ward.

  The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.

Study Arms (3)

Propofol

ACTIVE COMPARATOR

The patient underwent a routine upper gastrointestinal endoscopy.

Drug: Propofol

Remimazolam

EXPERIMENTAL

The patient underwent routine upper gastrointestinal endoscopy and Remimazolam was substituted for Propofol.

Drug: Remimazolam

Propofol + Remimazolam

EXPERIMENTAL

The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.

Drug: Remimazolam; Drug: Propofol

Interventions

Remimazolam DRUG

Remimazolam

Propofol + Remimazolam; Remimazolam

Propofol DRUG

Propofol dose reduction ratio

Propofol; Propofol + Remimazolam

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are between 20-80 years old.
• Anesthesiologists rated ASA as between I and III.
• Patients undergoing upper gastrointestinal endoscopic examination or therapy.

You may not qualify if:

• Allergy to Propofol, Remimazolam, or opioid medications.
• Emergency surgery.
• Pregnancy.
• History of malignant hyperthermia.
• Impaired liver or kidney function.
• Airway difficulties due to pharyngeal tumors.
• Refusal to participate.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

Related Publications (16)

• Meseeha M, Goosenberg E, Attia M. Endoscopic Retrograde Cholangiopancreatography. 2025 Oct 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493160/

  PMID: 29630212 RESULT

• Garewal D, Waikar P. Propofol sedation for ERCP procedures: a dilemna? Observations from an anesthesia perspective. Diagn Ther Endosc. 2012;2012:639190. doi: 10.1155/2012/639190. Epub 2012 Jan 5.

  PMID: 22272061 RESULT

• Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139.

  PMID: 23635608 RESULT

• Zhu H, Su Z, Zhou H, Lu J, Wang X, Ji Z, Chen S, Wang X, Yao M, Lu Y, Yu W, Su D. Remimazolam Dosing for Gastroscopy: A Randomized Noninferiority Trial. Anesthesiology. 2024 Mar 1;140(3):409-416. doi: 10.1097/ALN.0000000000004851.

  PMID: 38039392 RESULT

• Barbosa EC, Espirito Santo PA, Baraldo S, Meine GC. Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis. Br J Anaesth. 2024 Jun;132(6):1219-1229. doi: 10.1016/j.bja.2024.02.005. Epub 2024 Mar 4.

  PMID: 38443286 RESULT

• Dong SA, Guo Y, Liu SS, Wu LL, Wu LN, Song K, Wang JH, Chen HR, Li WZ, Li HX, Zhang L, Yu JB. A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures. J Clin Anesth. 2023 Jun;86:111077. doi: 10.1016/j.jclinane.2023.111077. Epub 2023 Feb 9.

  PMID: 36764022 RESULT

• Ahmer W, Imtiaz S, Alam DM, Ahmed K, Sajid B, Yousuf J, Asnani S, Fahim MAA, Ali R, Mansoor M, Safdar MT, Anjum MU, Hasanain M, Larik MO. Remimazolam versus propofol for sedation in gastrointestinal endoscopy and colonoscopy within elderly patients: a meta-analysis of randomized controlled trials. Eur J Clin Pharmacol. 2024 Apr;80(4):493-503. doi: 10.1007/s00228-024-03624-6. Epub 2024 Jan 23.

  PMID: 38261005 RESULT

• Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.

  PMID: 29723512 RESULT

• Yang SH, Wu CY, Tseng WH, Cherng WY, Hsiao TY, Cheng YJ, Chan KC. Nonintubated laryngomicrosurgery with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange: A case series. J Formos Med Assoc. 2019 Jul;118(7):1138-1143. doi: 10.1016/j.jfma.2018.11.009. Epub 2018 Dec 3.

  PMID: 30522856 RESULT

• Montgomery J, Melia L, O'Donnell N, MacKenzie K. Intubation trauma and the head and neck surgeon: issues with a shared airway. J R Soc Med. 2015 Nov;108(11):426-8. doi: 10.1177/0141076815614803. No abstract available.

  PMID: 26609095 RESULT

• Kuo YT, Chang TS, Tsai CC, Chang HC, Chia YY. Optimizing nonintubated laryngeal microsurgery: The effectiveness and safety of superior laryngeal nerve block with high-flow nasal oxygen-A prospective cohort study. J Chin Med Assoc. 2024 Mar 1;87(3):334-339. doi: 10.1097/JCMA.0000000000001057. Epub 2024 Jan 30.

  PMID: 38305707 RESULT

• Lewis SR, Pritchard MW, Fawcett LJ, Punjasawadwong Y. Bispectral index for improving intraoperative awareness and early postoperative recovery in adults. Cochrane Database Syst Rev. 2019 Sep 26;9(9):CD003843. doi: 10.1002/14651858.CD003843.pub4.

  PMID: 31557307 RESULT

• Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.

  PMID: 24937564 RESULT

• Wehrmann T. Extended monitoring of the sedated patient: bispectral index, Narcotrend and automated responsiveness monitor. Digestion. 2010;82(2):90-3. doi: 10.1159/000285506. Epub 2010 Apr 21.

  PMID: 20407252 RESULT

• Lee J, Jeong S, Lee DH, Park JS. Finding the ideal sedative: a non-inferiority study of remimazolam vs propofol in endoscopic retrograde cholangiopancreatography. J Gastroenterol Hepatol. 2023 Dec;38(12):2160-2166. doi: 10.1111/jgh.16354. Epub 2023 Sep 20.

  PMID: 37730240 RESULT

• Lee Y, Huang SJ, Lin PC, Lai HY, Pan MH. Low dose fentanyl and propofol improve the speed and quality of tidal-breathing induction techniques in sevoflurane anesthesia for adults. Acta Anaesthesiol Sin. 2001 Jun;39(2):83-8.

  PMID: 11475180 RESULT

MeSH Terms

Conditions

Postoperative Complications; Respiratory Insufficiency; Postoperative Nausea and Vomiting; Vomiting; Constipation

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• CHIA-HAO YANG, M.D

  employe

  PRINCIPAL INVESTIGATOR

• Tzung-Jim Tsai, M.D

  employe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan-Yi Chia, M.D

CONTACT

886-7-342-2121; yychia@vghks.gov.tw

Chen-Hsiu Chen, Ph.D

CONTACT

886-7-342-2121; chschen@vghks.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 16, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

TW (1)