Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy

N/ANot Yet RecruitingNCT07401914

Giresun University90 enrolled

Overview

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.

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

Conditions

Procedural Sedation Gastrointestinal Endoscopy

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: During the intraoperative period

Secondary Outcomes

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.

Time frame: 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

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