How Low Can we go: A Double-blinded Randomized Controlled Trial to Compare Bupivacaine 5 mg and Bupivacaine 7.5 mg for Spinal Anesthesia in Cesarian Delivery in Indonesian Population
Description:
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
prior conducting the study. Subjects will be recruited using consecutive sampling method.
Sample size was determined using alpha 5%, power 80%, and the difference of the incidence of
hypotension 20%. The sample of each group is 56 patients. The investigators will use ECG,
blood pressure monitoring, and pulse oxymetry for the standard monitoring. Patients will be
given oxygen 3 L/minute via nasal cannula. Before the spinal anesthesia, patients will be
given co-loading 500 ml of Ringer Lactate. Patients will be in sitting position while the
lumbal puncture is conducted using 27G Quincke in the level of L3-4 or L4-5 or Tuffier’s
line. After ensuring that the tip of the needle is in the subarachnoid space, the drug will
be administered with the speed of 0.2 mL/s. All the procedure will be conducted in sterile
condition. Patients will receive ketoprofen suppositoria as the postoperative analgesia and
can be discharged to the ward when the Aldrete’s score is more than 8.
The onset of sensoric blockade is assessed using pinprick test until the level of T6 or
maximum until 20 minute. The peak value will be recorded. The motor blockade will be assessed
using the Bromage scale. Incision will be done when the level of sensory block reached T6. If
patients report pain after delivery of the baby, intravenous fentanyl 0,67-1 mcg/kg will be
given twice with the interval of 10 minutes. If pain persists, conversion to general
anesthesia will be conducted.
The measurement of blood pressure, heart rate, respiratory rate, temperature, and O2
saturation will be recorded during the minute of 3, 6, 9, 12, 15, 20, 30, 40, 50, and 60
after the spinal anesthesia is administered or until the baby is delivered. Patients will be
recorded as hypotensive when she experienced reduction of blood pressure more than 30% from
baseline or systolic pressure less than 100 mmHg from the moment the spinal anesthesia is
administered until the baby is delivered. If the systolic pressure is less than 90 mmHg,
patient will be given ephedrine 5 mg iv that is repeated every minute until the systolic
pressure is over 90 mmHg.
The duration of the surgery is also recorded. Nausea, vomiting, syncope, dizziness, chest
discomfort, and other intraoperative complaint will be recorded. Postoperative nausea and
vomiting, itching, shivering, back pain, Post Dural Puncture Headache (PDPH), and Transient
Neurologic Symptoms (TNS) will also be recorded.
Condition:
Cesarean Section
Treatment:
Bupivacaine
Start Date:
October 1, 2013
Sponsor:
Indonesia University
For More Information:
https://clinicaltrials.gov/show/NCT03834454