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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D (Ketodex) | Patients receiving ketamine-dexmedetomidine sedation according to routine clinical practice. |
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| Group P (Ketofol) | Patients receiving ketamine-propofol sedation according to routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketodex | Drug | Administered as part of standard institutional anesthesia practice. |
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| 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 |
| 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. |
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Inclusion Criteria:
ASA I-II, adolescents aged 10-18 years undergoing elective gastrointestinal endoscopic procedures
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dilek YENİAY | Department of Anesthesiolgy, Giresun University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital | Giresun | Turkey (Türkiye) |
Individual participant data will not be shared due to ethical and confidentiality considerations.
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| Ketofol | Drug | Administered as part of standard institutional anesthesia practice. |
|
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| 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. |