Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403663
Status:
COMPLETED
Last Update Posted:
2009-07-30
First Post:
2006-11-23
Brief Title:
Effect of Body Mass Index on the Dose of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Effect of Body Mass Index on the ED95 of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Combined spinal - epidural CSE anesthesia is a well established technique used for elective Cesarean section As its name suggests it combines two anesthesia techniques - spinal and epidural Adjusting the dose of freezing medication for body size is not as simple as giving a larger dose to a larger person This study asks a simple yet important question does your body mass index BMI influence the amount of freezing medication needed for adequate CSE anesthesia for Cesarean section BMI is a number calculated from your height and weight In patients with a higher BMI freezing medication appears to spread farther to a higher level in the spinal fluid When freezing is too high it can cause unwanted side effects Therefore in order to provide optimal spinal anesthesia to patients with a higher BMI it may be advisable to administer less freezing medication In this study we want to find the ideal dose of freezing medication for patients with a higher body mass index and compare it to the dose found to be ideal for patients with normal body mass index
Detailed Description:
Spinal anesthesia is the most common anesthetic technique used for Cesarean section It offers many advantages over epidural and general anesthesia However one of the limitations of spinal anesthesia in Obstetrics is the use of a single shot technique as the continuous technique is associated with unacceptable incidence of PDPH It is difficult to predict the exact level of sensory block because many factors affect the spread of local anesthetic injected into the CSF Theoretically obese patients may have greater intra-abdominal pressure leading to compression of the inferior vena cava and engorgement of the epidural venous plexus which in turn increases the pressure inside the epidural space This augmented pressure is transmitted to the dural sac and diverge the CSF from the lumbosacral region leading to a decrease in CSF volume It has been demonstrated that the volume of CSF in lumbosacral region is an important factor affecting intrathecal spread of anesthetics
Our hypothesis is that obese women require less intrathecal hyperbaric bupivacaine than do normal weight women to achieve satisfactory surgical anesthesia for elective Cesarean sectionTwo groups of patients will be studied separately Patients with BMI greater than or equal to 30 will be included in the obese group also denominated study group Patients with BMI less than 25 will be included in the normal weight group also denominated control group BMI will be calculated based on the patients pre-pregnancy weight For each group the up-down sequential allocation method based on the Narayana rule will be used to find the minimum effective dose of intrathecal hyperbaric bupivacaine 075 associated with opioids necessary for satisfactory outcome in 95 of the pregnant women undergoing cesarean section ie ED95
There are two possible outcomes in our study a satisfactory outcome is defined if the sensory block reaches at least at T6 and the patient does not complain of any pain or discomfort that requires intraoperative supplemental drugs an unsatisfactory outcome is defined if the sensory block reaches a level lower than T6 or the patient complains of pain or discomfort that requires intraoperative supplemental drugs The decision whether or not the supplementation is required will be made exclusively by the patient and not by the physician in charge
Our hypothesis is that obese women require less intrathecal hyperbaric bupivacaine than do normal weight women to achieve satisfactory surgical anesthesia for elective Cesarean sectionTwo groups of patients will be studied separately Patients with BMI greater than or equal to 30 will be included in the obese group also denominated study group Patients with BMI less than 25 will be included in the normal weight group also denominated control group BMI will be calculated based on the patients pre-pregnancy weight For each group the up-down sequential allocation method based on the Narayana rule will be used to find the minimum effective dose of intrathecal hyperbaric bupivacaine 075 associated with opioids necessary for satisfactory outcome in 95 of the pregnant women undergoing cesarean section ie ED95
There are two possible outcomes in our study a satisfactory outcome is defined if the sensory block reaches at least at T6 and the patient does not complain of any pain or discomfort that requires intraoperative supplemental drugs an unsatisfactory outcome is defined if the sensory block reaches a level lower than T6 or the patient complains of pain or discomfort that requires intraoperative supplemental drugs The decision whether or not the supplementation is required will be made exclusively by the patient and not by the physician in charge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-0206-E | None | None | None |