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Active, Not Recruiting

NCT Number: NCT07401914

Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Procedural Sedation Gastrointestinal Endoscopy

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital

Giresun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketodex

Drug

Administered as part of standard institutional anesthesia practice.

Other names: Ketamine-Dexmedetomidine

Ketofol

Drug

Administered as part of standard institutional anesthesia practice.

Other names: Ketamine-Propofol

Primary outcomes

  1. Intraoperative patient comfort assessed by Ramsey Sedation Scale

    Time frame: During the intraoperative period

    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.

  2. Intraoperative additional anesthetic drug requirement

    Time frame: During the intraoperative period

    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.

Secondary outcomes

  1. Postoperative recovery time assessed by recovery score

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

    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.

  2. Emergence agitation assessed by emergence agitation score

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

    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

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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