Postoperative; ParotitisGenderOpioidNCT03006627
Gender and Opioid Consumption
A study testing postoperative morphine in people with Postoperative; Parotitis, run by Mansoura University.
Trial summary
Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Postoperative; Parotitis
- What is being tested?
- postoperative morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 2017
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I and II Cases scheduled for elective intraabdominal surgeries
Who cannot join
- diabetes,
- postmenopausal females,
- laparoscopic surgery,
- regional anesthesia emergency procedures,
- sepsis,
- hepatectomy,
Show all 9Show fewer
- Renal impairment, and
- hepatic impairment,
- mental and psychiatric disorders.
About this study
Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea \& vomiting, itching, over-sedation, delayed intestinal motility).
- Conditions
- Postoperative; Parotitis
- Being tested
- postoperative morphine
- Medical subject headings
- Parotitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative morphineDrug
Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| Male group | Active comparator | All male patients scheduled for upper abdominal surgeries Receives: Drug: postoperative morphine |
| Female group | Active comparator | All female patients scheduled for upper abdominal surgeries Receives: Drug: postoperative morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative; ParotitisStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006627
- Sponsor's protocol ID
- GenderOpioids
- Acronym
- GenderOpioid
- Status last verified
- Dec 2016
- First submitted
- 27 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender and Opioid Consumption
- ClinicalTrials.gov ID
- NCT03006627
- Acronym / sponsor ID
- GenderOpioid / GenderOpioids
- Conditions
- Postoperative; Parotitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- 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.
Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea \& vomiting, itching, over-sedation, delayed intestinal motility).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male group | Active comparator | Drug: postoperative morphineAll male patients scheduled for upper abdominal surgeries |
| Female group | Active comparator | Drug: postoperative morphineAll female patients scheduled for upper abdominal surgeries |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I and II Cases scheduled for elective intraabdominal surgeries
Key exclusion criteria (9 listed)
- diabetes,
- postmenopausal females,
- laparoscopic surgery,
- regional anesthesia emergency procedures,
- sepsis,
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 |
|---|---|---|
| postoperative morphinePostoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min. | Drug | Female group, Male group |
Primary outcome
postoperative morphine consumption
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative morphine in people with Postoperative; Parotitis, run by Mansoura University.
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 9 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
postoperative morphine consumption (time frame: 24 hours after surgery). 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 30 Dec 2016.