Postoperative NauseaNCT03387956
Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting
A study testing Intrathecal atropine and dexamethasone in people with Postoperative Nausea, run by Assiut University at 1 site in Egypt.
Trial summary
optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postoperative Nausea
- What is being tested?
- Intrathecal atropine and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2017to 10 Aug 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- females
- 18-40 years of age
- elective cesarean delivery under bupivacaine spinal anesthesia
Who cannot join
- renal disease
- preeclampsia
- liver disease
- cardiac disease
- Coagulopathy
- chronic cough
Show all 9Show fewer
- nausea
- vomiting
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Dexamethasone Combined With Intrathecal Atropine to Prevent Morphine-related Nausea and Vomiting After Cesarean Delivery: A Randomized Double-blinded Study
optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting.
Read the detailed description
One of the gold standards for analgesia following cesarean delivery is intrathecal morphine, which is not devoid of complications namely postoperative nausea and vomiting. We evaluated the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after cesarean delivery under spinal bupivacaine plus morphine anesthesia.
- Conditions
- Postoperative Nausea
- Being tested
- Intrathecal atropine, dexamethasone
- Keywords
- Postoperative Nuasea
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal atropineDrug
100ug intrathecal atropine will be injected with spinal anesthesia
dexamethasoneDrug
intravenous 8 mg dexamethasone (2ml).
| Study group | Role | What they receive |
|---|---|---|
| Atropine group | Active comparator | Atropine group (A): Patients received intrathecal heavy Marcaine, 2 ml, 0.5% plus 300 µg morphine and 100 µg atropine (0.5ml), and intravenous injection of 2ml normal saline. Receives: Drug: Intrathecal atropine |
| Dexamethasone group | Active comparator | Dexamethasone group (D): Patients received intrathecal heavy Marcaine 2 ml, 0.5% plus 300 µg morphine (0.5ml), and intravenous 8 mg dexamethasone (2ml). Receives: Drug: dexamethasone |
| Dexamethasone and Atropine group | Active comparator | Dexamethasone and Atropine group (DA): Patients received intrathecally as group A, plus intravenous injection of 2 ml, dexamethasone 8 mg. Postoperative follow-up of both nausea and vomiting was done over 24 hours postoperative. Receives: Drug: Intrathecal atropine; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea
Monitoring scale of nausea and vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start20 Mar 2017
- Primary completion28 Jul 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387956
- Sponsor's protocol ID
- IRB00009916
- Status last verified
- Jun 2018
- First submitted
- 20 Dec 2017
- Last updated
- 6 Jun 2018
- 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 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone Combined With Intrathecal Atropine to Prevent Morphine-related Nausea and Vomiting After Cesarean Delivery: A Randomized Double-blinded Study
- ClinicalTrials.gov ID
- NCT03387956
- Acronym / sponsor ID
- IRB00009916
- Conditions
- Postoperative Nausea
- Keywords
- Postoperative Nuasea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 2 Jan 2018 (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.
optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting.
Detailed description
One of the gold standards for analgesia following cesarean delivery is intrathecal morphine, which is not devoid of complications namely postoperative nausea and vomiting. We evaluated the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after cesarean delivery under spinal bupivacaine plus morphine anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atropine group | Active comparator | Drug: Intrathecal atropineAtropine group (A): Patients received intrathecal heavy Marcaine, 2 ml, 0.5% plus 300 µg morphine and 100 µg atropine (0.5ml), and intravenous injection of 2ml normal saline. |
| Dexamethasone group | Active comparator | Drug: dexamethasoneDexamethasone group (D): Patients received intrathecal heavy Marcaine 2 ml, 0.5% plus 300 µg morphine (0.5ml), and intravenous 8 mg dexamethasone (2ml). |
| Dexamethasone and Atropine group | Active comparator | Drug: Intrathecal atropine, Drug: dexamethasoneDexamethasone and Atropine group (DA): Patients received intrathecally as group A, plus intravenous injection of 2 ml, dexamethasone 8 mg. Postoperative follow-up of both nausea and vomiting was done over 24 hours postoperative. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- females
- 18-40 years of age
- elective cesarean delivery under bupivacaine spinal anesthesia
Key exclusion criteria (9 listed)
- renal disease
- preeclampsia
- liver disease
- cardiac disease
- Coagulopathy
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 |
|---|---|---|
| Intrathecal atropine100ug intrathecal atropine will be injected with spinal anesthesia | Drug | Atropine group, Dexamethasone and Atropine group |
| dexamethasoneintravenous 8 mg dexamethasone (2ml). | Drug | Dexamethasone and Atropine group, Dexamethasone group |
Primary outcome
postoperative nausea
Time frame: 24 hours
Monitoring scale of nausea and vomiting
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 6 Jun 2018.
- 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.
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 study testing Intrathecal atropine and dexamethasone in people with Postoperative Nausea, run by Assiut 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 3 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: finished, as of the sponsor's last update on 6 Jun 2018. 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?
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?
postoperative nausea (time frame: 24 hours). 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 6 Jun 2018.