Post-Operative ShiveringEarly Phase 1NCT04682743
Prevention of Post-Operative Shivering
A Early Phase 1 study testing paracetamol, ondansetron and normal saline in people with Post-Operative Shivering, run by Cairo University at 1 site in Egypt.
Trial summary
Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia. paracetamol is an antipyretic drug that has been in clinical use for a long time. It can lower the BT of febrile and nonfebrile patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post-Operative Shivering
- What is being tested?
- paracetamol, ondansetron and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2021to 22 Feb 2022
- Phase
- Early Phase 1
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients between 18-40 years.
- ASA physical status I and II
- Both genders
- Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia
Who cannot join
- Patients who refused to participate in the study,
- ASA physical status more than II,
- any contraindications to regional anesthesia,
- surgical duration less than two hours or exceeding six hours,
- giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders,
- any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation,
- Finally if their body temperature was recorded to surpass 37.5ºC or <36.5°C before enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering
Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia.
paracetamol is an antipyretic drug that has been in clinical use for a long time.
It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.
- Conditions
- Post-Operative Shivering
- Being tested
- paracetamol, ondansetron, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
received intravenous one gram of paracetamol over a 15-minute period,
ondansetronDrug
received intravenous 8 mg of ondansetron over a 15-minute period.
normal salineDrug
received intravenous 0.9% normal saline over a 15-minute period.
| Study group | Role | What they receive |
|---|---|---|
| saline group | Sham comparator | Not described Receives: Drug: normal saline |
| ondansetron group | Active comparator | Not described Receives: Drug: ondansetron |
| paracetamol group | Active comparator | Not described Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shivering
60 min postoperatively
Measured: UP TO 1 HOURE
Secondary outcomes (2)
The assessment the core temperatures
temperatures
Measured: UP TO 24 HOURE
postoperative shivering scores
"0" indicated no shivering; "1," piloerection or peripheral vasoconstriction, but no visible shivering; "2," muscular activity in only 1 muscle group; "3," muscular activity in >1 muscle group, but not generalized; and "4," shivering involving the whole body.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start6 Jan 2021
- Primary completion16 Jan 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative ShiveringStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682743
- Sponsor's protocol ID
- N-122-2020
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering
- ClinicalTrials.gov ID
- NCT04682743
- Acronym / sponsor ID
- N-122-2020
- Conditions
- Post-Operative Shivering
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 24 Dec 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.
Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia.
paracetamol is an antipyretic drug that has been in clinical use for a long time.
It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| saline group | Sham comparator | Drug: normal saline |
| ondansetron group | Active comparator | Drug: ondansetron |
| paracetamol group | Active comparator | Drug: paracetamol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients between 18-40 years.
- ASA physical status I and II
- Both genders
- Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia
Key exclusion criteria (7 listed)
- Patients who refused to participate in the study,
- ASA physical status more than II,
- any contraindications to regional anesthesia,
- surgical duration less than two hours or exceeding six hours,
- giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders,
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 |
|---|---|---|
| paracetamolreceived intravenous one gram of paracetamol over a 15-minute period, | Drug | paracetamol group |
| ondansetronreceived intravenous 8 mg of ondansetron over a 15-minute period. | Drug | ondansetron group |
| normal salinereceived intravenous 0.9% normal saline over a 15-minute period. | Drug | saline group |
Primary outcome
Incidence of shivering
Time frame: UP TO 1 HOURE
60 min postoperatively
2 secondary outcomes
The assessment the core temperatures
Time frame: UP TO 24 HOURE
postoperative shivering scores
Time frame: up to 2 hours
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 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing paracetamol, ondansetron and normal saline in people with Post-Operative Shivering, run by Cairo 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 4 inclusion and 7 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 31 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of shivering (time frame: UP TO 1 HOURE). 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 31 Mar 2022.