Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy

The Effect of Anesthesia Protocols Used in Gastrointestinal Endoscopy Procedures in Adolescents on the Outcome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Endoscopy; Procedural Sedation
• Intervention / Treatment: Drug: Ketodex; Drug: Ketofol

Detailed Description

Gastrointestinal endoscopic (GE) procedures require the use of sedoanalgesic agents to ensure patient comfort and procedural safety. In adolescent patients, deep sedation is often necessary to provide adequate procedural comfort and to prevent agitation. Additionally, GE procedures are inherently painful and require the use of analgesic medications as part of routine practice. The scientifically accepted approach involves the use of low-dose combinations of different anesthetic agents. The selection of the sedoanalgesia protocol during the procedure is shaped by patient characteristics as well as the experience and preference of the attending anesthesiologist.

The aim of this study is to evaluate the effects of routinely used sedoanalgesia protocols, specifically ketodex and ketofol, on intraoperative procedural comfort, postoperative recovery, and patient satisfaction in adolescent patients undergoing gastrointestinal endoscopy.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Giresun, Turkey (Türkiye)
    • Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group D (Ketodex); Patients receiving ketamine-dexmedetomidine sedation according to routine clinical practice.	Drug: Ketodex; Administered as part of standard institutional anesthesia practice.; Other Names: Ketamine-Dexmedetomidine
Group P (Ketofol); Patients receiving ketamine-propofol sedation according to routine clinical practice.	Drug: Ketofol; Administered as part of standard institutional anesthesia practice.; Other Names: Ketamine-Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recovery time assessed by recovery score	Postoperative recovery time was assessed using a standardized recovery score evaluating the patient's level of consciousness and readiness for discharge from the postanesthesia care unit. Higher scores indicate better recovery status.	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	Emergence agitation was evaluated using a validated emergence agitation scoring system. The scale assesses the severity of agitation during emergence from anesthesia, with higher scores indicating greater levels of agitation.between the ketodex and ketofol groups during the procedure	From the end of anesthesia until discharge from the postanesthesia care unit, assessed up to 24 hours postoperatively.

Collaborators and Investigators

• Sponsor: Giresun University
• Investigators: Principal Investigator: Dilek YENİAY, Department of Anesthesiolgy, Giresun University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Actual): April 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GOKAEK 2025/13/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to ethical and confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No