Dose-sparing Balanced Propofol Sedation in Colonoscopy

NCT07885059 | Completed

• 1 other identifier: PROP-MIDFEN-RCT-2022
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial compared two balanced propofol analgosedation strategies in adults undergoing elective colonoscopy. Participants were randomized to either a standard-dose protocol using an initial propofol dose of 1.0 mg/kg or a structured dose-sparing protocol using an initial propofol dose of 0.5 mg/kg. Both protocols included midazolam and fentanyl. The standard-dose protocol was anesthesiologist-guided, whereas the dose-sparing protocol was administered by a gastroenterologist trained in advanced life support and airway management, with an anesthesia technician present and an anesthesiologist immediately available if required. The primary outcomes were patient satisfaction and clinically relevant respiratory adverse events, with apnea lasting more than 30 seconds as the principal respiratory safety endpoint. Secondary outcomes included propofol exposure, recovery, procedural performance, cardiovascular adverse events, depth of sedation and nociception-related indices, and endoscopist satisfaction.

Conditions

Colonoscopy; Sedation and Analgesia

Keywords

Colonoscopy; Gastroenterologist-guided sedation; Anaesthesiologist-guided sedation; Propofol; Midazolam; Fentanyl; Balanced Propofol sedation; Analgosedation

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction

  Patient satisfaction was assessed using a study-specific four-item questionnaire. Two items assessed satisfaction with the colonoscopy procedure and satisfaction with analgosedation using separate 11-point numerical rating scales ranging from 0 (completely dissatisfied) to 10 (extremely satisfied). Two additional binary items assessed whether the participant would recommend the same approach to relatives or friends and whether the participant would agree to undergo colonoscopy using the same approach again.

  At completion of post-procedural recovery on the day of colonoscopy.

• Incidence of clinically relevant respiratory adverse events

  Incidence of protocol-defined respiratory adverse events, reported by event type. Respiratory events included apnea lasting more than 30 seconds, oxygen saturation below 90%, respiratory rate below 10 or above 20 breaths per minute, end-tidal CO2 below 35 mmHg, and the need for airway-opening interventions. Apnea lasting more than 30 seconds was analyzed as the principal respiratory safety endpoint.

  From administration of sedation through completion of monitored post-procedural recovery on the day of colonoscopy.

Secondary Outcomes (17)

• Total propofol dose

  From initial propofol administration until completion of the colonoscopy.

• Number of additional propofol boluses

  From initial propofol administration until completion of the colonoscopy.

• Cumulative additional propofol dose

  From initial propofol administration until completion of the colonoscopy.

• Early recovery time

  From completion of colonoscopy through the early post-procedural recovery period on the day of the procedure.

• Total recovery time

  From completion of colonoscopy until completion of monitored post-procedural recovery on the day of the procedure.

Study Arms (2)

Standard-dose balanced propofol analgosedation

ACTIVE COMPARATOR

Intravenous midazolam 0.05 mg/kg (maximum 5 mg), followed by fentanyl 0.001 mg/kg and an initial propofol bolus of 1.0 mg/kg. Additional propofol boluses of 10-30 mg were administered according to clinical need. Sedation and monitoring were guided by an anesthesiologist with an anesthesia technician present.

Drug: Standard-dose balanced propofol analgosedation

Dose-sparing balanced propofol analgosedation

EXPERIMENTAL

Intravenous midazolam 0.05 mg/kg (maximum 5 mg), followed by fentanyl 0.001 mg/kg and an initial propofol bolus of 0.5 mg/kg. Additional propofol boluses of 10-30 mg were administered according to clinical need. Sedation and monitoring were guided by a gastroenterologist trained in advanced life support and airway management, with an anesthesia technician present and an anesthesiologist immediately available if required.

Drug: Dose-sparing balanced propofol analgosedation

Interventions

Standard-dose balanced propofol analgosedation DRUG

Intravenous balanced analgosedation with midazolam, fentanyl, and propofol. Midazolam was administered at 0.05 mg/kg, up to a maximum dose of 5 mg. Fentanyl 0.001 mg/kg was administered 3 minutes later, followed by an initial propofol bolus of 1.0 mg/kg at minute 5. Additional propofol boluses of 10-30 mg were administered according to clinical need and patient response during colonoscopy. Sedation and monitoring were guided by an anaesthesiologist with an anaesthesia technician present.

Also known as: Standard-dose balanced propofol sedation, Anaesthesiologist-guided balanced propofol analgosedation

Standard-dose balanced propofol analgosedation

Dose-sparing balanced propofol analgosedation DRUG

Intravenous balanced analgosedation with midazolam, fentanyl, and propofol. Midazolam was administered at 0.05 mg/kg, up to a maximum dose of 5 mg. Fentanyl 0.001 mg/kg was administered 3 minutes later, followed by an initial propofol bolus of 0.5 mg/kg at minute 5. Additional propofol boluses of 10-30 mg were administered according to clinical need and patient response during colonoscopy. Sedation and monitoring were guided by a gastroenterologist trained in advanced life support and airway management, with an anaesthesia technician present and an anaesthesiologist immediately available if required.

Also known as: Dose-sparing balanced propofol sedation, Gastroenterologist-guided balanced propofol analgosedation

Dose-sparing balanced propofol analgosedation

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective diagnostic colonoscopy
• Ability to provide written informed consent

You may not qualify if:

• ASA physical status IV or higher
• Mallampati class III or higher
• Known allergy or contraindication to any of the study medications, including propofol, midazolam, or fentanyl
• Known allergy or contraindication to soy or egg products
• Known sleep apnea
• History of seizures
• Previous colonic surgery
• Planned therapeutic colonoscopy or planned endoscopic intervention
• Pregnancy or lactation
• Psychiatric disorder or long-term use of psychotropic medication
• Inability to complete the study questionnaires

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• University Hospital of Split: collaborator

Study Sites (2)

Polyclinic J&J Medici

Split, Split-Dalmatia County, 21000, Croatia

Location

University Hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zarko Ardalic, MD

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to the type of sedation and sedation provider (anaesthesiologist vs gastroenterologist). Care providers and outcome assessors were not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized in an intended 1:1 ratio to a standard-dose balanced propofol analgosedation protocol or a structured dose-sparing protocol. Allocation was performed using sealed opaque envelopes prepared before enrollment. Participants were blinded to study-group allocation. Because of the nature of the intervention, sedation providers and the procedural team were not blinded.

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: June 5, 2022
• Primary Completion: February 3, 2024
• Study Completion: February 8, 2024
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and for 5 years thereafter.
• Access Criteria: Requests should include a scientifically justified research proposal describing the objectives, planned analyses, and intended use of the data. Requests will be reviewed by the study investigators for scientific validity, feasibility, participant confidentiality, and compliance with applicable ethical and data-protection requirements. Deidentified data will be provided only after approval of the request and, where required, execution of an appropriate data-use agreement.

Locations

CR (2)