The Effect of Anesthesia Protocols Used in Gastrointestinal Endoscopy Procedures in Adolescents on the Outcome
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Giresun University
- Enrollment
- 90
- Primary Endpoint
- Intraoperative patient comfort assessed by Ramsey Sedation Scale
Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group D (Ketodex)
Patients receiving ketamine-dexmedetomidine sedation according to routine clinical practice.
Intervention: Ketodex (Drug)
Group P (Ketofol)
Patients receiving ketamine-propofol sedation according to routine clinical practice.
Intervention: Ketofol (Drug)
Outcomes
Primary Outcomes
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.
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
- 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.)
Investigators
Dilek Yeniay
Anesthesiology and Reanimation physician
Giresun University