Obstructive Sleep ApneaNCT04483427
Multimodal Postoperative Analgesia Following OSA Surgery
A study testing Nalbuphine, ketorolac, accufuser in people with Obstructive Sleep Apnea, run by Bahaa Mohammed Refaie at 1 site in Egypt.
Trial summary
Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Nalbuphine, ketorolac, accufuser
- 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
- 20 Sep 2020to Dec 2022
- Phase
- Interventional
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- physical status of American Society of Anesthesiologists (ASA) II
- age between 30 - 50 years
- OSA patients diagnosed by polysomnography and stop-bang questionnaire
- enrolled for multilevel OSA surgery
Who cannot join
- history of allergy to the study drugs
- history of hepatic, cardiopulmonary or renal disease
- history of any chronic pain on medication
- history of substance abuse
- psychiatric disorder
- lack of patient cooperation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag faculty of medicine
Sohag, 82524
Bahaa M Refaie, MD
About this study
Official title: Multimodal Postoperative Analgesia Using Accufuser for Multilevel Surgery for Obstructive Sleep Apnea (OSA)
Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Nalbuphine, ketorolac, accufuser
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine, ketorolac, accufuserCombination product
multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)
| Study group | Role | What they receive |
|---|---|---|
| OSA patients after multilevel surgery | Experimental | Not described Receives: Combination Product: Nalbuphine, ketorolac, accufuser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
visual analog pain score
Measured: Assessment will be carried out at zero time (time to shift to PACU) .
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 6 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 12 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 18 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 24 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 30 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 36 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 42 hours postoperatively
Postoperative pain
Visual analog pain score
Measured: Assessment will be carried out 48 hours postoperatively
Secondary outcomes (18)
Sedation level
Ramsey sedation scale
Measured: Zero time ( time to shift to PACU)
Sedation level
Ramsey sedation scale
Measured: 6 hours postoperatively
Sedation level
Ramsey Sedation Scale
Measured: 12 hours postoperatively
Sedation level
Ramsey Sedation Scale
Measured: 18 hours postoperatively
Sedation level
Ramsey Sedation Scale
Measured: 24 hours postoperatively
Sedation level
Ramsey Sedation scale
Measured: 30 hours postoperatively
Sedation level
Ramsey Sedation Scale
Measured: 36 hours postoperatively
Sedation level
Ramsey Sedation Scale
Measured: 42 hours postoperatively
Sedation level
Ramsey Sedation Ramsey Sedation Scale
Measured: 48 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: Zero time ( time to shift to PACU)
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 6 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 12 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 18 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 24 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 30 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 36 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 42 hours postoperatively
incidence of adverse effects
hypoxia, nausea, vomiting, itching
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start20 Sep 2020
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahaa Mohammed Refaie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahaa Mohammed Refaie, Sohag University
- Investigators
- Bahaa M Refaie, MD, Principal investigator, Lecturer of anesthesia and ICU sohag universityMohammed E Ahmed, MD, Study director, Lecturer of ENT sohag universityA M Elhalwagy, MD, Study chair, Consultant of pain medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483427
- Sponsor's protocol ID
- 1984
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Postoperative Analgesia Using Accufuser for Multilevel Surgery for Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT04483427
- Acronym / sponsor ID
- 1984
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bahaa Mohammed RefaieUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jul 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.
Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA patients after multilevel surgery | Experimental | Combination Product: Nalbuphine, ketorolac, accufuser |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- physical status of American Society of Anesthesiologists (ASA) II
- age between 30 - 50 years
- OSA patients diagnosed by polysomnography and stop-bang questionnaire
- enrolled for multilevel OSA surgery
Key exclusion criteria (6 listed)
- history of allergy to the study drugs
- history of hepatic, cardiopulmonary or renal disease
- history of any chronic pain on medication
- history of substance abuse
- psychiatric disorder
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 |
|---|---|---|
| Nalbuphine, ketorolac, accufusermultimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) | Combination product | OSA patients after multilevel surgery |
Primary outcome
Postoperative pain
Time frame: Assessment will be carried out at zero time (time to shift to PACU) .
visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 6 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 12 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 18 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 24 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 30 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 36 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 42 hours postoperatively
Visual analog pain score
Postoperative pain
Time frame: Assessment will be carried out 48 hours postoperatively
Visual analog pain score
18 secondary outcomes
Sedation level
Time frame: Zero time ( time to shift to PACU)
Sedation level
Time frame: 6 hours postoperatively
Sedation level
Time frame: 12 hours postoperatively
Sedation level
Time frame: 18 hours postoperatively
Sedation level
Time frame: 24 hours postoperatively
Sedation level
Time frame: 30 hours postoperatively
Sedation level
Time frame: 36 hours postoperatively
Sedation level
Time frame: 42 hours postoperatively
Sedation level
Time frame: 48 hours postoperatively
incidence of adverse effects
Time frame: Zero time ( time to shift to PACU)
incidence of adverse effects
Time frame: 6 hours postoperatively
incidence of adverse effects
Time frame: 12 hours postoperatively
incidence of adverse effects
Time frame: 18 hours postoperatively
incidence of adverse effects
Time frame: 24 hours postoperatively
incidence of adverse effects
Time frame: 30 hours postoperatively
incidence of adverse effects
Time frame: 36 hours postoperatively
incidence of adverse effects
Time frame: 42 hours postoperatively
incidence of adverse effects
Time frame: 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Bahaa M Refaie, MD principal investigator
Lecturer of anesthesia and ICU sohag university
Mohammed E Ahmed, MD study director
Lecturer of ENT sohag university
A M Elhalwagy, MD study chair
Consultant of pain medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalbuphine, ketorolac, accufuser in people with Obstructive Sleep Apnea, run by Bahaa Mohammed Refaie 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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahaa M Refaie, MD (0201026887257, bahaarefaay@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Assessment will be carried out at zero time (time to shift to PACU) .). The study lists 9 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 28 Sep 2021.