NCT06288542

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 25, 2024

Last Update Submit

February 25, 2024

Conditions

Keywords

dextrose infusionpostoperative nausea and vomitinggynecological laparoscope and hysteroscope

Outcome Measures

Primary Outcomes (1)

  • frequency of post-opertive nausea and vomiting in 24 hour

    using verbal rating scale (VRS)

    FROM ENROLLMENT TO 24 HOURS AFTER SURGERY

Secondary Outcomes (1)

  • TOTAL AMOUNT OF ANTIEMETIC REQUIRED

    From end of surgery to 24 hours postoperative

Study Arms (3)

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

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

Other: group R

Interventions

group dOTHER

this group will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia

Also known as: dextrose group
group d
group ROTHER

this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia

Also known as: ringer group
group r

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I and ll.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

VomitingPostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNausea

Central Study Contacts

yasmin yasmin hassabelnaby, assistant profesour

CONTACT

yasmin s hassabelnaby, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 1, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02