Procedural SedationNCT07401914
Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy
An observational study of Procedural Sedation and Gastrointestinal Endoscopy, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Procedural Sedation, Gastrointestinal Endoscopy
- What is being tested?
- Ketodex and Ketofol
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 30 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- ASA I-II, adolescents aged 10-18 years undergoing elective gastrointestinal endoscopic procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital
Giresun
About this study
Official title: 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.
Read the 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.
- Conditions
- Procedural Sedation, Gastrointestinal Endoscopy
- Being tested
- Ketodex, Ketofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetodexDrug
Also called Ketamine-Dexmedetomidine
Administered as part of standard institutional anesthesia practice.
KetofolDrug
Also called Ketamine-Propofol
Administered as part of standard institutional anesthesia practice.
| Study group | Role | What they receive |
|---|---|---|
| Group D (Ketodex) | Patients receiving ketamine-dexmedetomidine sedation according to routine clinical practice. Receives: Drug: Ketodex | |
| Group P (Ketofol) | Patients receiving ketamine-propofol sedation according to routine clinical practice. Receives: Drug: Ketofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the intraoperative period
Secondary outcomes (2)
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.
Measured: 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
Measured: From the end of anesthesia until discharge from the postanesthesia care unit, assessed up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start2 Feb 2026
- Primary completion30 Apr 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yeniay, Giresun University
- Investigators
- Dilek YENİAY, Principal investigator, Department of Anesthesiolgy, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401914
- Sponsor's protocol ID
- GOKAEK 2025/13/19
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia Protocols Used in Gastrointestinal Endoscopy Procedures in Adolescents on the Outcome
- ClinicalTrials.gov ID
- NCT07401914
- Acronym / sponsor ID
- GOKAEK 2025/13/19
- Conditions
- Procedural Sedation, Gastrointestinal Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Ketodex) | – | Drug: KetodexPatients receiving ketamine-dexmedetomidine sedation according to routine clinical practice. |
| Group P (Ketofol) | – | Drug: KetofolPatients receiving ketamine-propofol sedation according to routine clinical practice. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- ASA I-II, adolescents aged 10-18 years undergoing elective gastrointestinal endoscopic procedures
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetodexAlso: Ketamine-DexmedetomidineAdministered as part of standard institutional anesthesia practice. | Drug | Group D (Ketodex) |
| KetofolAlso: Ketamine-PropofolAdministered as part of standard institutional anesthesia practice. | Drug | Group P (Ketofol) |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek YENİAY principal investigator
Department of Anesthesiolgy, Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Sedation and Gastrointestinal Endoscopy, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative patient comfort assessed by Ramsey Sedation Scale (time frame: During the intraoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.