NCT07809230

Brief Summary

"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine. Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Sep 2026Feb 2027

First Submitted

Initial submission to the registry

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 1, 2026

Last Update Submit

September 4, 2026

Conditions

Colonoscopy ProceduresSedation

Keywords

colonoscopy proceduressedationpropofolketaminebispectral index

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Pressure

    Evaluation of Mean Arterial Pressure (MAP)

    Baseline, at induction, and every 3 minutes until the end of the procedure

Secondary Outcomes (2)

  • Bispectral Index (BIS) Values

    Intraoperative (Continuous monitoring from baseline to the end of the procedure)

  • Total Propofol Consumption

    At the end of the procedure

Study Arms (2)

Propofol Group

ACTIVE COMPARATOR

Patients receiving standard propofol sedation according to routine clinical practice during elective colonoscopy

Procedure: Propofol group

Propofol + Ketamine Group

ACTIVE COMPARATOR

Patients receiving standard propofol sedation combined with low-dose ketamine (0.25 mg/kg) according to routine clinical practice during elective colonoscopy

Procedure: Propofol + Ketamine

Interventions

Propofol groupPROCEDURE

Patients in this group will receive standard propofol sedation titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy

Propofol Group
Propofol + KetaminePROCEDURE

Patients in this group will receive a combination of standard propofol sedation and low-dose ketamine (0.25 mg/kg). Propofol will be titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy

Propofol + Ketamine Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective colonoscopy
  • ASA physical status I-II

You may not qualify if:

  • ASA physical status ≥ III
  • Allergy to propofol or ketamine
  • History of psychiatric illness
  • Advanced cardiac disease
  • Pregnancy
  • Chronic use of opioids or sedatives
  • Inability to cooperate
  • Body Mass Index (BMI) \> 35 kg/m\^2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

PropofolKetamine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, Alicyclic

Central Study Contacts

Berat DAĞDELEN

CONTACT

00905538861406brtdagdelen@gmail.com

Aslı DÖNMEZ

CONTACT

00905322256473aslidonmez@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 9, 2026

Study Start

September 14, 2026

Primary Completion (Estimated)

January 14, 2027

Study Completion (Estimated)

February 14, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations

TU(1)