Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy

NCT07401914 | Not Yet Recruiting

• 1 other identifier: GOKAEK 2025/13/19
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastrointestinal endoscopic procedures in adolescents require effective sedoanalgesia to ensure procedural comfort and prevent agitation. Pain control is an essential component of these procedures, and current practice commonly involves low-dose combinations of anesthetic agents. Sedoanalgesia protocols are selected according to patient characteristics and the anesthesiologist's clinical experience. This prospective observational study aims to compare the effects of ketodex and ketofol on intraoperative procedural comfort, postoperative recovery, and patient satisfaction in adolescents undergoing gastrointestinal endoscopy.

Conditions

Procedural Sedation; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (2)

• Intraoperative patient comfort assessed by Ramsey Sedation Scale

  Intraoperative patient comfort was evaluated using the Ramsey Sedation Scale, a 6-point clinical scale assessing the level of sedation and patient responsiveness. The scale ranges from 1 to 6, where lower scores indicate agitation or anxiety and higher scores indicate deeper sedation and better patient comfort.

  During the intraoperative period

• Intraoperative additional anesthetic drug requirement

  The requirement for additional anesthetic medication administered during the intraoperative period was recorded. Additional anesthetic use was determined based on clinical signs of inadequate sedation or patient discomfort as judged by the attending anesthesiologist.

  During the intraoperative period

Secondary Outcomes (2)

• Postoperative recovery time assessed by recovery score

  From the end of surgery until discharge from the postanesthesia care unit, assessed up to 24 hours postoperatively.

• Emergence agitation assessed by emergence agitation score

  From the end of anesthesia until discharge from the postanesthesia care unit, assessed up to 24 hours postoperatively.

Study Arms (2)

Group D (Ketodex)

Patients receiving ketamine-dexmedetomidine sedation according to routine clinical practice.

Drug: Ketodex

Group P (Ketofol)

Patients receiving ketamine-propofol sedation according to routine clinical practice.

Drug: Ketofol

Interventions

Ketodex DRUG

Administered as part of standard institutional anesthesia practice.

Also known as: Ketamine-Dexmedetomidine

Group D (Ketodex)

Ketofol DRUG

Administered as part of standard institutional anesthesia practice.

Also known as: Ketamine-Propofol

Group P (Ketofol)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent patients scheduled to undergo gastrointestinal endoscopic procedures under sedation as part of routine clinical care will be included in the study. Patients will receive either ketamine-dexmedetomidine (ketodex) or ketamine-propofol (ketofol) sedation according to standard institutional practice and the preference of the attending anesthesiologist.

You may qualify if:

• ASA I-II, adolescents aged 10-18 years undergoing elective gastrointestinal endoscopic procedures

You may not qualify if:

• Emergency cases
• Children under 10 years of age
• Children with mental retardation
• Children whose parents refuse to participate in the study and children who do not consent to participate themselves
• Children with known allergy, hypersensitivity, intolerance or contraindication to any of the sedoanalgesic drugs used

Sponsors & Collaborators

• Giresun University: lead

Study Officials

• Dilek YENİAY

  Department of Anesthesiolgy, Giresun University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DİLEK YENİAY

CONTACT

+905375521553; dgyeniay@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation physician

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 11, 2026
• Study Start: February 2, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share