Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Location status: Recruiting
NCT Number: NCT06701929
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
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Observational
Montreal, Quebec, H3T1E2, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
Obstetric quality of recovery after c-section, which has been validated based on the total score of 11 questions, with total scores ranging from 0 to 110, where 0 is the worst, and 110 is the best.
Time frame: 24 hours
The presence of nausea vomiting or retching during or within 24 hours of surgery
Time frame: 2 hours after surgery
Rating of pain, on a scale where 0 is no pain, and 10 is the worst pain imaginable.
Contact information is provided by the study sponsor or research team.
Jewish General Hospital
Other
How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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