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.
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.
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.
- Conditions
- Gynecological Abdominal Surgeries
- 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 group | Role | What they receive |
|---|---|---|
| group I | Placebo comparator | patients will receive infused IV 0.9 % saline |
| Study group II | Experimental | patients will receive 5 % dextrose infusion |
| Study group III | Experimental | patients 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.
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.
- First posted10 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gynecological Abdominal SurgeriesStudies 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 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fareed Fathy Wadea, Assiut University
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 32310996Kim 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 30762734Jewer 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 31536172Wiesmann 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 25866213Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.
PubMed 17885699Balaban 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 27450627Koju 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dextrose Versus Saline Infusion on Intrathecal Morphine-Induced Postoperative Nausea and Vomiting During Gynecological Abdominal Surgeries: Randomized Controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT06726980
- Acronym / sponsor ID
- Dextrose vs Saline Gyn surg
- Conditions
- Gynecological Abdominal Surgeries
- Keywords
- Nausea, Vomiting, Dextrose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 10 Dec 2024 (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.
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).
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.
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 |
|---|---|---|
| group I | Placebo comparator | –patients will receive infused IV 0.9 % saline |
| Study group II | Experimental | –patients will receive 5 % dextrose infusion |
| Study group III | Experimental | –patients will receive 10 % dextrose infusion (25gm/ 250 mL) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20 - 60 years. Females of American Society of Anesthesiologists (ASA) class I or II physical status.
- Elective gynecological abdominal surgeries under intrathecal anesthesia.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| dextrose 5%patients will receive 5 % dextrose infusion | Drug | – |
| Dextrose 10%patients will receive 10 % dextrose infusion (25gm/ 250 mL) | Drug | – |
| 0.9% salinepatients will receive infused IV 0.9 % saline | Drug | – |
Primary outcome
Incidence of postoperative nausea and vomiting( PONV)
Time frame: 24 hours
Incidence of PONV during the first postoperative 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Results publication: PubMed 32310996Yokoyama 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.
- Results publication: PubMed 30762734Kim 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.
- Results publication: PubMed 31536172Jewer 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.
- Results publication: PubMed 25866213Wiesmann 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.
- Results publication: PubMed 17885699Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.
- Results publication: PubMed 27450627Balaban 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.
- Results publication: PubMed 25971957Koju 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.
- Individual participant dataSharing planned: Undecided
Related trials for Gynecological Abdominal Surgeries
RecruitingObservational study
Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery
Post-Operative Hematoma at Operative Site (Diagnosis), Post-Operative Hemorrhage
Not yet recruiting
Suprapubic Transverse Incision With Rectus Release for Upper Peritoneal Access): A Novel Dual-Plane Technique for Abdominal Wall Incision in Complex Gynecological Surgery
Post-Op Complication
Recruiting
Enhanced Vitals Monitoring After Major Surgery Trial
Surgery, Post Operative Complications
Enrolling by invitation
The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms
Gynecologic Surgeries, Physical Therapy
Enrolling by invitation
COMPARISON OF PLAIN BLOCKS FOR POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES
Surgery With General Anesthesia, Gynecologic Surgical Procedures
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.
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.