An interventional study of Phenylephrine in Complications; Cesarean Section and Hypotension, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-26.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Prevention
At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a short acting opioid fentanyl (to increase block density) and a long acting opioid morphine (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean section.However, larger doses of local anesthetic drug when used in caesarean section commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an effect of the spinal anesthetic as it is harmful to both mother and the baby. The investigators propose that the extent of surgical anesthetic block, which is dependent on height and weight in our adjusted dose group, will provide adequate anesthesia for surgery and minimise maternal low blood pressure.
Study design is prospective, randomized, double blind, placebo controlled.
Patients presenting for elective cesarean section under neuraxial block and meeting inclusion criteria will be randomized to two groups:
Group 1: Fixed dose group: Bupivacaine 12 mg, Fentanyl 15 mcg, Morphine 100 mcg Group 2: Height and weight adjusted bupivacaine dose, fentanyl 15 mcg, morphine 100 mcg Patients are fasted as per Canadian guidelines prior to the procedure. All patients have an IV cannula inserted,baseline vitals recorded and routine blood work checked prior to blockade. Routine monitoring (as per Canadian Anesthesia Society (CAS) guidelines) occur during and after the procedure. This includes pulse oximetry (SpO2), ECG and non-invasive blood pressure (NIBP). NIBP monitoring occurs every two minutes for the first 20 minutes post spinal and every 5 minutes thereafter. Oxygen via Hudson mask or nasal prongs is available if required.
Spinal anesthetic is performed with standard doses of drugs and the level of sensory block is tested with ice. Motor block is tested with Bromage scale just before prepping and draping. Once deemed adequate, surgery begins. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. After surgery, patients are monitored in a recovery area until fit to be transferred to their rooms. If patient reports extreme discomfort or sharp pain during the surgery,conversion to general anesthetic is as per the discretion of the attending anesthesiologist.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 160 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA I and II patients aged 18-40 > 37 weeks gestation
Exclusion Criteria:
Contraindication to neuraxial blockade
Patients in this group receive height and weight adjusted dose for spinal anesthesia.During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors .
Drug: Phenylephrine
Patients in this group receive a fixed standard dose for spinal anesthesia. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors .
Drug: Phenylephrine
100 mcg of phenylephrine or 5 mg ephedrine given as deemed necessary for treating episodes of hypotension.
Also known as: Ephedrine
Maternal hypotension needing vasopressors.
Time frame: Until the end of surgery
Time to adequate surgical anesthetic block
Time frame: 24 hours after the surgery
incidence of nausea, vomiting, pruritus, and respiratory depression
Time frame: 24 hours after the surgery
conversion to general anesthesia due to block failure
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's