Effect of Dextrose on Postoperative Nausea and VomitingNCT06288542
Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting
A study testing group d and group R in people with Effect of Dextrose on Postoperative Nausea and Vomiting, run by Cairo University.
Trial summary
This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Effect of Dextrose on Postoperative Nausea and Vomiting
- What is being tested?
- group d and group R
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 May 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients scheduled for elective laparoscopic gynecological/hysteroscopic procedures will be considered for inclusion
- ASA physical status I and ll.
Who cannot join
- patients with a previous history of PONV.
- Patients with motion sickness, coagulopathy, diabetes mellitus, or severe hypertension
- patients with cardiac, renal or hepatic dysfunction.
- patients receiving an antiemetic agent within 24 h before surgery or cases where complications occurs during the surgery
- patients who have abnormal blood glucose on the night before surgery
- patients who are unable to understand and use the verbal rating scale (VRS);Growth developmental, and motor-mental retardation.
Trial locations and contacts
No sites are listed yet.
yasmin s hassabelnaby, assistant professor contact
About this study
Official title: The Relationship of Preoperative Intravenous Dextrose Infusion to Postoperative Nausea and Vomiting in Gynecological Laparoscopic and Hysteroscopic Surgeries: A Randomized Control Trial
This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures
Read the detailed description
A history of PONV risk factors will be recorded. After consenting, patients will be assigned using a computerized randomization function to Ringer solution (group R) or 5% dextrose (group D) or control group (group C). Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia. Group R will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia. Group C will receive no fluids. The anesthesia providers, surgeons, perioperative nurses, postanesthesia care unit (PACU) nurses and investigators will be blinded to group assignment throughout.
As for pre-medication, all patients will receive IV midazolam (0.02 mg/kg). Anesthesia will be induced with propofol (1.5-2 mg/kg), fentanyl (1-2 μg/kg) and atracurium(o.5mg/kg) to facilitate endotracheal intubation. The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2/air. Intraoperative IV maintenance fluid will be standardized at 3 mL/kg/h with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased \>20% from baseline. For postoperative pain relief, paracetamol 1 g will be given I.V. during surgery in all patients and continued orally after operation (1g every 6 h). In addition, all patients will be ambulated within 6 h after completion of surgery. Standardized antiemetic and analgesic rescue medications will be available. Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2; 1 dose of rescue medication when the VRS score is 3 to 6; and ≥2 doses for nausea score of 7 to 10, to reduce the nausea score to 0 to 2.
- Being tested
- group d, group R
- Keywords
- dextrose infusion, postoperative nausea and vomiting, gynecological laparoscope and hysteroscope
- Medical subject headings
- Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group dOther
Also called dextrose group
this group will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia
group ROther
Also called ringer group
this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group c | No intervention | control group . this group will not receive any iv fluids |
| group d | Experimental | Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia Receives: Other: group d |
| group r | Active comparator | this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia Receives: Other: group R |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of post-opertive nausea and vomiting in 24 hour
using verbal rating scale (VRS)
Measured: FROM ENROLLMENT TO 24 HOURS AFTER SURGERY
Secondary outcomes (1)
TOTAL AMOUNT OF ANTIEMETIC REQUIRED
Measured: From end of surgery to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Dextrose on Postoperative Nausea and VomitingStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Hassab elnaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288542
- Sponsor's protocol ID
- MD-250-2022
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Preoperative Intravenous Dextrose Infusion to Postoperative Nausea and Vomiting in Gynecological Laparoscopic and Hysteroscopic Surgeries: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06288542
- Acronym / sponsor ID
- MD-250-2022
- Keywords
- dextrose infusion, postoperative nausea and vomiting, gynecological laparoscope and hysteroscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 Mar 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.
This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures
Detailed description
A history of PONV risk factors will be recorded. After consenting, patients will be assigned using a computerized randomization function to Ringer solution (group R) or 5% dextrose (group D) or control group (group C). Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia. Group R will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia. Group C will receive no fluids. The anesthesia providers, surgeons, perioperative nurses, postanesthesia care unit (PACU) nurses and investigators will be blinded to group assignment throughout.
As for pre-medication, all patients will receive IV midazolam (0.02 mg/kg). Anesthesia will be induced with propofol (1.5-2 mg/kg), fentanyl (1-2 μg/kg) and atracurium(o.5mg/kg) to facilitate endotracheal intubation. The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2/air. Intraoperative IV maintenance fluid will be standardized at 3 mL/kg/h with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased \>20% from baseline. For postoperative pain relief, paracetamol 1 g will be given I.V. during surgery in all patients and continued orally after operation (1g every 6 h). In addition, all patients will be ambulated within 6 h after completion of surgery. Standardized antiemetic and analgesic rescue medications will be available. Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2; 1 dose of rescue medication when the VRS score is 3 to 6; and ≥2 doses for nausea score of 7 to 10, to reduce the nausea score to 0 to 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group c | No intervention | –control group . this group will not receive any iv fluids |
| group d | Experimental | Other: group dGroup D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia |
| group r | Active comparator | Other: group Rthis group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult female patients scheduled for elective laparoscopic gynecological/hysteroscopic procedures will be considered for inclusion
- ASA physical status I and ll.
Key exclusion criteria (6 listed)
- patients with a previous history of PONV.
- Patients with motion sickness, coagulopathy, diabetes mellitus, or severe hypertension
- patients with cardiac, renal or hepatic dysfunction.
- patients receiving an antiemetic agent within 24 h before surgery or cases where complications occurs during the surgery
- patients who have abnormal blood glucose on the night before 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 |
|---|---|---|
| group dAlso: dextrose groupthis group will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia | Other | group d |
| group RAlso: ringer groupthis group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia | Other | group r |
Primary outcome
frequency of post-opertive nausea and vomiting in 24 hour
Time frame: FROM ENROLLMENT TO 24 HOURS AFTER SURGERY
using verbal rating scale (VRS)
1 secondary outcome
TOTAL AMOUNT OF ANTIEMETIC REQUIRED
Time frame: From end of surgery to 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Related trials for Effect of Dextrose on Postoperative Nausea and Vomiting
Not yet recruitingPhase 4
Effects of Dextrose Versus Saline Infusion on Intrathecal Morphine-Induced Postoperative Nausea and Vomiting During Gynecological Abdominal Surgeries: Randomized Controlled Double-blind Study
Gynecological Abdominal Surgeries
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.
yasmin s hassabelnaby, assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing group d and group R in people with Effect of Dextrose on Postoperative Nausea and Vomiting, run by Cairo 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 6 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 1 Mar 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. 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?
Contact yasmin yasmin hassabelnaby, assistant profesour (+201006719987, yalnaby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of post-opertive nausea and vomiting in 24 hour (time frame: FROM ENROLLMENT TO 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 1 Mar 2024.