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AzTrials

Gynecological Abdominal SurgeriesPhase 4NCT06726980

Effects of Dextrose Versus Saline Infusion on Intrathecal Morphine-Induced Postoperative Nausea and Vomiting During Gynecological Abdominal Surgeries: Randomized Controlled Double-blind Study

A Phase 4 study testing dextrose 5%, Dextrose 10% and 0.9% saline in people with Gynecological Abdominal Surgeries, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Neuraxial anesthesia, which includes epidural anesthesia and intrathecal anesthesia, is a frequent anesthetic approach for cesarean delivery and other lower abdominal and lower limb anesthetic procedures. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Gynecological Abdominal Surgeries
What is being tested?
dextrose 5%, Dextrose 10% and 0.9% saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 1 Feb 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age: 20 - 60 years. Females of American Society of Anesthesiologists (ASA) class I or II physical status.
  • Elective gynecological abdominal surgeries under intrathecal anesthesia.

Who cannot join

  • Patient refusal. Patients with a history of PONV, smoking, motion sickness or diabetes mellitus. Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
  • Morbid obesity (BMI >35 kg/m²). Patients with known hypersensitivity to morphine or amide local anesthetics. Patients with any contraindication for intrathecal anesthesia, e.g. coagulopathy.
  • Emergency operations. Psychiatric disorders or patients who are unable to understand the verbal rating scale.
  • Failed or unsatisfactory intrathecal block. Patients currently receiving opioids, steroids, antiemetic drugs or chemotherapy, pregnant females, and those with abnormal blood glucose on the morning of surgery.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fareed Fathy Wadea Daneal, resident doctor contact

+2 01223814266

Fareed.16266190@med.aun.edu.eg

About this study

Neuraxial anesthesia, which includes epidural anesthesia and intrathecal anesthesia, is a frequent anesthetic approach for cesarean delivery and other lower abdominal and lower limb anesthetic procedures.

Neuraxial morphine (intrathecal or epidural administration) provides high-quality analgesia after gynecological abdominal surgeries.

the aim of the study is to compare the effects of intraoperative infusion of dextrose 5 % and 10 % versus normal saline 0.9 % on the incidence of intrathecal morphine-induced postoperative nausea and vomiting (PONV) in women undergoing gynecological abdominal surgeries. (Neuraxial anesthesia).

Read the detailed description

The use of intrathecal opioids for postoperative analgesia was introduced in 1979. There have been many pharmacodynamic and pharmacokinetic studies of intrathecal opioids and the mechanism of action-producing analgesic effects by direct action at the spinal cord level. The addition of intrathecal opioids to bupivacaine for spinal anesthesia may provide clinical advantages such as improved intraoperative conditions and postoperative analgesia. Adverse effects range from nausea and vomiting that, although not life-threatening, are major nuisances to the patient, to more severe effects, including sedation and life-threatening respiratory depression.

Nausea is an unpleasant sensation causing discomfort in the stomach area which gives the feeling of the impending need to vomit or retch. It is often a transient sensation which is frequently followed by active retching or tachycardia and increased salivation. Vomiting is the involuntary, forceful expulsion of the contents of the stomach through the mouth and/or nose. The incidence of these side effects varies from 30-80 % after elective surgery depending on the type of anesthesia and surgery as well as predisposing patient risk factors.

Postoperative nausea and vomiting (PONV) describes nausea and/or vomiting or retching occurring in the post-anesthesia care unit (PACU) or during the first 24-48 hours after surgery. Post-discharge nausea and vomiting (PDNV) refers to symptoms that occur after discharge from the hospital or surgical care facility. Not only is PONV a distressing complication from the patient's perspective but also it can result in dehydration, electrolyte imbalance, acid base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, suture rupture, wound dehiscence, bleeding, delay in the ability to resume oral intake, prolonged PACU and/or hospital stay, fatigue, anxiety, unanticipated hospital admission or readmission, and increased medical costs. The distressing symptoms of PONV/PDNV also contribute to patient dissatisfaction with their surgical experience. PONV prophylaxis is economically beneficial for the hospital when a rational multimodal program is implemented based on patient and procedural risk factors.

Enhanced recovery programs in surgical patients and the promotion of day case surgery both require and include adequate prophylaxis of PONV. There are dozens of different anti-emetic drugs, mostly within the drug classes of 5- hydroxytryptamine-3 (5HT3), dopamine-2 (D2) and neurokinin-1 (NK1) receptor antagonists, corticosteroids, antihistamines and anticholinergics. Varying adverse effects have been attributed to the six different substance classes, such as headache and constipation (5-HT3 receptor antagonists); extrapyramidal symptoms, sedation, arrhythmia and QT prolongation (D2 receptor antagonists); hyperglycemia, immunosuppression and poor wound healing (corticosteroids); drowsiness, dry mouth and urinary difficulties (antihistamines); and dry mouth and visual disturbances (anticholinergics).

In addition to pharmacological therapy, recent studies are assessing the impact of fluid therapy in the prevention of PONV, finding that the use of crystalloids in ASA I and II patients receiving general anesthesia reduces the risk of postoperative nausea. and a preventive effect of vomiting during the first 24 hrs post-surgery[15]. Another fluid therapy strategy for PONV is the administration of colloids, which has had a superior effect in preventing PONV than the administration of crystalloids in patients undergoing lower abdominal surgery who received general anesthesia for 3 hours or more[16]; however, these results are not the same in patients who received general anesthesia for less than 3 hours. On the other hand, the administration of bolus glucose solution is still very controversial, since some results show that it does not reduce PONV [17], while Chisaki et al. (2020) reported its usefulness in reducing postoperative nausea, but not vomiting.

These last fluid therapy recommendations should be handled with caution, since the risk of serious adverse events resulting from the supplementary administration of intravenous crystalloids and colloids is unknown, and it is not clear whether patients are at risk of being readmitted to the hospital postoperatively due to these interventional measures.

Being tested
dextrose 5%, Dextrose 10%, 0.9% saline
Keywords
Nausea, Vomiting, Dextrose
Medical subject headings
Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dextrose 5%Drug

    patients will receive 5 % dextrose infusion

  • Dextrose 10%Drug

    patients will receive 10 % dextrose infusion (25gm/ 250 mL)

  • 0.9% salineDrug

    patients will receive infused IV 0.9 % saline

Study groups in NCT06726980
Study groupRoleWhat they receive
group IPlacebo comparatorpatients will receive infused IV 0.9 % saline
Study group IIExperimentalpatients will receive 5 % dextrose infusion
Study group IIIExperimentalpatients will receive 10 % dextrose infusion (25gm/ 250 mL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative nausea and vomiting( PONV)

    Incidence of PONV during the first postoperative 24 hours

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726980
Sponsor's protocol ID
Dextrose vs Saline Gyn surg
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
10 Dec 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yokoyama C, Mihara T, Kashiwagi S, Koga M, Goto T. Effects of intravenous dextrose on preventing postoperative nausea and vomiting: A systematic review and meta-analysis with trial sequential analysis. PLoS One. 2020 Apr 20;15(4):e0231958. doi: 10.1371/journal.pone.0231958. eCollection 2020.

    PubMed 32310996
  • Kim HJ, Choi SH, Eum D, Kim SH. Is perioperative colloid infusion more effective than crystalloid in preventing postoperative nausea and vomiting?: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Feb;98(7):e14339. doi: 10.1097/MD.0000000000014339.

    PubMed 30762734
  • Jewer JK, Wong MJ, Bird SJ, Habib AS, Parker R, George RB. Supplemental peri-operative intravenous crystalloids for postoperative nausea and vomiting: an abridged Cochrane systematic review. Anaesthesia. 2020 Feb;75(2):254-265. doi: 10.1111/anae.14857. Epub 2019 Sep 19.

    PubMed 31536172
  • Wiesmann T, Kranke P, Eberhart L. Postoperative nausea and vomiting - a narrative review of pathophysiology, pharmacotherapy and clinical management strategies. Expert Opin Pharmacother. 2015 May;16(7):1069-77. doi: 10.1517/14656566.2015.1033398. Epub 2015 Apr 12.

    PubMed 25866213
  • Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.

    PubMed 17885699
  • Balaban CD, Yates BJ. What is nausea? A historical analysis of changing views. Auton Neurosci. 2017 Jan;202:5-17. doi: 10.1016/j.autneu.2016.07.003. Epub 2016 Jul 16.

    PubMed 27450627
  • Koju RB, Gurung BS, Dongol Y. Prophylactic administration of ondansetron in prevention of intrathecal morphine-induced pruritus and post-operative nausea and vomiting in patients undergoing caesarean section. BMC Anesthesiol. 2015 Feb 17;15:18. doi: 10.1186/1471-2253-15-18.

    PubMed 25971957

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dextrose 5%, Dextrose 10% and 0.9% saline in people with Gynecological Abdominal Surgeries, run by Assiut 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Dec 2024. 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. 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?

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fareed Fathy Wadea Daneal, resident doctor (+2 01223814266, Fareed.16266190@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative nausea and vomiting( PONV) (time frame: 24 hours). 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 NCT06726980, which also lists 7 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 Dec 2024.

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