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RecruitingNCT06701929

The Impact of Fasting Duration on Quality of Recovery After Cesarean Section

How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)

Status
Recruiting
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Jewish General Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting

Detailed description

This is a prospective observational study aiming to evaluate the impact of fasting time before cesarean section on the quality of recovery after c-section. All patients presenting for elective cesarean section with low transverse incision, under spinal anesthesia will be considered for inclusion. The primary outcome will be the ObsQoR-11 score approximately 24 hours after surgery. Secondary outcomes will include the presence of nausea, vomiting or retching during surgery, the volume of intravenous fluid administered, the dose of vasopressor administered, the pain scores two hours after surgery, and the dose of opioid used in the 24 hours after surgery. The primary analysis will be a linear regression to determine if there is a statistically significant correlation between fasting time and the ObsQoR-11 score while factoring in the variables mentioned above. Secondary analyses will determine if the fasting duration correlates with a change in any of the eleven components of the ObsQoR-11 score or the secondary outcomes listed. In addition, the fasting data will be plotted against the ObsQoR-11 score to determine if an inflection point is present. Ten observations will be obtained for each independent variable included in the model, for a total of 100 patients in the study.

Conditions

Timeline

Start date
2025-03-18
Primary completion
2025-12-01
Completion
2026-06-01
First posted
2024-11-22
Last updated
2025-09-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06701929. Inclusion in this directory is not an endorsement.