Trial · NCT04490031
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
NCT04490031, Phase 4, Recruiting, Universiti Kebangsaan Malaysia Medical Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP). Trials, record NCT04490031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04490031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
- NCT number
- NCT04490031
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Conditions
- Ketamine Adverse Reaction
- Interventions
- Ketamine Hydrochloride
- First posted
- 2020-07-28
- Last updated
- 2020-07-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | depth of sedation | 1 hour | based on Ramsay Sedation Scale, from a scale of 1-6. 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response The aim of sedation is a score of 3-4 |
| Primary | completion rate | 1 hour | to evaluate completion rate between Ketamine and Midazolam group |
| Secondary | Surgeon satisfaction score | within 4 hours after completion of ERCP | subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent |
| Secondary | Patient satisfaction score | within 4 hours after completion of ERCP | subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent |
| Secondary | evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms | 24 hours | recording the adverse events of each sedation. 1. Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg 2. Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg 3. Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute 4. Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute 5. Hypoxia: defined by oxygen saturation less than 95% 6. Respiratory rate abnormality 7. Nausea, vomiting, emergence symptoms |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04490031
GET https://conductscience.org/api/trials/v1/NCT04490031/registered