Thinking of joining a study?

Register your interest

NCT06701929 | NOT YET RECRUITING | Quality Improvement


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

Jewish General Hospital

Information provided by (Responsible Party):

Matthew Cameron, MDCM MPH

Brief 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

Condition or disease

Quality Improvement

Quality of Recovery From Anaesthesia

Cesarean Section

Fasting ( 6H for Solid ; 2H for Clear Fluid )

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)
Actual Study Start Date : 2025-03-18
Estimated Primary Completion Date : 2025-06-01
Estimated Study Completion Date : 2025-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Presenting for elective c-section under spinal anesthesia
Exclusion Criteria
  • * Unable to communicate in French or English
  • * Urgent c-section
  • * Planned general anesthesia

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

Location Details

NCT06701929


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


No Location Found

Loading...