Sleep Apnea SyndromesPhase 4NCT04452383
f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea
A Phase 4 study testing Ketamine + propofol and propofol in people with Sleep Apnea Syndromes, run by Zagazig University at 1 site in Egypt.
Trial summary
The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Ketamine + propofol and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2024to 30 Dec 2025
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- American society of anesthesiologists (ASA) physical status I or II. I / II
Who cannot join
- patient refusal
- American society of anesthesiologists (ASA) physical status > III
- known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans
- morbid obesity
- patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study
The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy
Read the detailed description
Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural sedation.
The investigator compared the effect of propofol and propofol ketamine in patients undergoing drug induced sleep endoscopy.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Ketamine + propofol, propofol
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine + propofolDrug
Also called ketamine
effect of adding ketamine to propofol for patients undergoing DISE surgery
propofolDrug
Also called diprivan
effect of IV propofol alone for patients undergoing DISE surgery
| Study group | Role | What they receive |
|---|---|---|
| propofol (P) | Active comparator | patients will receive only propofol intravenous for sedation Receives: Drug: propofol |
| propofol ketamine (pk) | Active comparator | patients will receive ketamine in addition to propofol intravenous for sedation Receives: Drug: Ketamine + propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
Measured: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure
Secondary outcomes (7)
time until sufficient sedation to start endoscopy
time to start endoscopy is defined as the duration between start of the studied drugs until MOAA/S Modified observer assessment scale of alertness sedaion score 1 was obtained.
Measured: It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy
The total propofol and ketamine dose(mg)/patient needed/patient was calculated
The total propofol and ketamine(mg) /patient dose needed/patient was calculated
Measured: the procedure
any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction
Once the DISE began, the airway interventions were important as outcomes, because these interrupted the clinical study of the DISE. Furthermore, laryngospasm was defined by the requirement for positive pressure ventilation of >20 cmH2O or administration of succinylcholine or propofol or any .
Measured: the procedure
Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure
Bradycardia was diagnosed if heart rate dropped below 60beats/min and atropine 0.01mg/kg was given if HR decreased below 50beats/min. Hypotension was diagnosed if mean arterial blood pressure (MAP) decreased by more than 30% from baseline or below 60mmHg
Measured: the procedure
Time till Recovery
Time between stop of the study drugs until Modified observer's assessment of alertness sedation MOAA/S score of 4 was calculated and patient is shifted to recovery room( MOAA/S score btween 0-6 where 1 patient is ready for endoscopic airway evaluation and 1 patient is ready for discharge to recovery room ) Time till (MOAA/S) score 4 was calculated .
Measured: an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4
patients and surgeon satisfaction
Both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied
Measured: about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied
Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room
Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded post procedure in the recovery room
Measured: Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Jul 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba Mohamed EL -Asser,MD, Zagazig University
- Investigators
- Heba M EL-Asser, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452383
- Sponsor's protocol ID
- Sedation in DISE
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho JS, Soh S, Kim EJ, Cho HJ, Shin S, Kim HJ, Koo BN. Comparison of three sedation regimens for drug-induced sleep endoscopy. Sleep Breath. 2015 May;19(2):711-7. doi: 10.1007/s11325-015-1127-9. Epub 2015 Feb 3.
PubMed 25643766De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.
PubMed 20811901
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04452383
- Acronym / sponsor ID
- Sedation in DISE
- Conditions
- Sleep Apnea Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 30 Jun 2020 (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.
The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy
Detailed description
Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural sedation.
The investigator compared the effect of propofol and propofol ketamine in patients undergoing drug induced sleep endoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol (P) | Active comparator | Drug: propofolpatients will receive only propofol intravenous for sedation |
| propofol ketamine (pk) | Active comparator | Drug: Ketamine + propofolpatients will receive ketamine in addition to propofol intravenous for sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old.
- American society of anesthesiologists (ASA) physical status I or II. I / II
Key exclusion criteria (6 listed)
- patient refusal
- American society of anesthesiologists (ASA) physical status > III
- known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans
- morbid obesity
- patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease
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 |
|---|---|---|
| Ketamine + propofolAlso: ketamineeffect of adding ketamine to propofol for patients undergoing DISE surgery | Drug | propofol ketamine (pk) |
| propofolAlso: diprivaneffect of IV propofol alone for patients undergoing DISE surgery | Drug | propofol (P) |
Primary outcome
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
Time frame: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
7 secondary outcomes
time until sufficient sedation to start endoscopy
Time frame: It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy
The total propofol and ketamine dose(mg)/patient needed/patient was calculated
Time frame: the procedure
any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction
Time frame: the procedure
Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure
Time frame: the procedure
Time till Recovery
Time frame: an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4
patients and surgeon satisfaction
Time frame: about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied
Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room
Time frame: Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room
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 10 Sep 2026.
- Background: PubMed 25643766Cho JS, Soh S, Kim EJ, Cho HJ, Shin S, Kim HJ, Koo BN. Comparison of three sedation regimens for drug-induced sleep endoscopy. Sleep Breath. 2015 May;19(2):711-7. doi: 10.1007/s11325-015-1127-9. Epub 2015 Feb 3.
- Background: PubMed 20811901De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.
- Individual participant dataSharing planned: No
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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.
Heba M EL-Asser, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine + propofol and propofol in people with Sleep Apnea Syndromes, run by Zagazig University at 1 site in Egypt.
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 2 inclusion and 6 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 10 Sep 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction) (time frame: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452383, which also lists 2 linked publications.
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 10 Sep 2026.