Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bupivacaine 5 mg vs 7.5 mg for Spinal Anesthesia in Cesarean Delivery in Indonesian Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03834454
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Susilo Chandra, Indonesia University

Brief Summary:
This study aims to evaluate the efficacy of hyperbaric 5 mg bupivacaine + fentanyl 25 mcg versus hyperbaric 7.5 mg bupivacaine + fentanyl 25 mcg to lower incidence of hypotension

Condition or disease Intervention/treatment Phase
Cesarean Section Hypotension Drug-Induced Spinal Anesthesia Postoperative Complications Drug: Bupivacaine Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Simple randomization will be conducted using a software by one of the researchers (HA) into two groups with equal size. To ensure the concealment, the randomization list will be kept in a sealed enveloped and opened by the physician who administered the spinal anesthesia just before the surgery. Data recording will be conducted by independent observers. This is a double-blinded study for the subjects and for the observers. The enrollment of the participants will be conducted by HA. Patients will not be notified about the dose scheme. Physician who performed the spinal anesthesia are different from the observers. Observers are junior residents trained to test the spinal adequacy and to perform monitoring in spinal anesthesia. It us not possible to blind the physicians who perform the spinal anesthesia because they will notice the volume difference.
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : December 31, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine 5 mg
5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
Drug: Bupivacaine
5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
Other Name: 5 mg hyperbaric bupivacaine 0.5%

Active Comparator: Bupivacaine 7.5 mg
7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
Drug: Bupivacaine
7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
Other Name: 7.5 mg hyperbaric bupivacaine 0.5%




Primary Outcome Measures :
  1. Incidence of hypotension [ Time Frame: 60 minutes ]
    recorded during the minute of 3, 6, 9, 12, 15, 20, 30, 40, 50, and 60 after the spinal anesthesia will be administered or until the baby is delivered


Secondary Outcome Measures :
  1. Adequacy of Anesthesia [ Time Frame: 120 minutes ]
    Requirement of additional local anesthetics

  2. Quality of anesthesia: as reported by patients and surgeons [ Time Frame: 120 minutes ]
    Quality of anesthesia as reported by patients and surgeons

  3. Motor recovery [ Time Frame: 10 hours ]
    Duration of motor recovery after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women with ASA PS 1-3
  • age 18-40 years old
  • in an elective or emergency cesarean delivery using spinal anesthesia

Exclusion Criteria:

  • patients with contraindication of spinal anesthesia
  • have history of allergy to bupivacaine or fentanyl
  • with eclampsia
  • valvular heart disease
  • congenital heart disease
  • coronary heart disease
  • twin pregnancy
  • morbid obesity (BMI >=40)
  • pre-partum hemorrhage with hemodynamic instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834454


Locations
Layout table for location information
Indonesia
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Publications:

Layout table for additonal information
Responsible Party: Susilo Chandra, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03834454     History of Changes
Other Study ID Numbers: IndonesiaUAnes027
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susilo Chandra, Indonesia University:
pregnancy
caesarean section
spinal anesthesia
bupivacaine
opioid
hypotension
intraoperative
postoperative

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Postoperative Complications
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Bupivacaine
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General