search
Back to results

Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section

Primary Purpose

Respiratory Depression

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SOMNOTOUCH RESP
Caesarean section
Spinal anesthesia with intrathecal morphine
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Depression focused on measuring Elective Caesarean Section, obese women, BMI≥30, spinal anesthesia combined with intrathecal morphine

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnancy
  • Healthy women

Exclusion Criteria:

  • Heart diseases
  • Autoimmune diseases
  • Respiratory diseases

Sites / Locations

  • Rambam healthcare campusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

women BMI<30 POD 1

women BMI≥30 POD 1

women BMI<30 POD4

women BMI≥30 POD 4

Arm Description

Pregnant healthy women with BMI<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.

Pregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.

Pregnant healthy women with BMI<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.

Pregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.

Outcomes

Primary Outcome Measures

Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring

Secondary Outcome Measures

Full Information

First Posted
June 15, 2016
Last Updated
May 27, 2018
Sponsor
Rambam Health Care Campus
search

1. Study Identification

Unique Protocol Identification Number
NCT02819661
Brief Title
Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section
Official Title
Difference in the Frequency of Episodes of Respiratory Depression Between Obese (BMI≥30) and Women With Normal BMI Receiving Spinal Anesthesia Combined With Intrathecal Morphine During Elective Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will examine whether there is a difference in the frequencies of respiratory depression among obese women receiving spinal anesthesia combined with opioids compared to women with normal BMI. If such a risk exists further investigation will be required to establish the proper criteria for the administration of morphine with spinal anesthesia to obese women.
Detailed Description
Since 1979, intrathecal morphine combined with spinal anesthesia has been shown to provide effective postoperative analgesia in a variety of surgeries and more specifically in caesarean sections. The advantages of addition of morphine to spinal analgesia are in prolonged analgesia during the operation and post operatively. In addition the analgesia is provided using a single injection during the time of surgery with no further need for complex and costly instruments like an opioid pump . The side effects and risks of intrathecal morphine include: nausea, vomiting, pruritus urinary retention and the most severe being respiratory depression (immediate or delayed). The mild side effects were higher postoperatively in patients receiving spinal anesthesia combined with morphine. In a meta-analysis study of different surgeries performed under spinal anesthesia, it has been shown that at low doses (<0.3mg) intrathecal morphine does not increase the rate of respiratory depression. Nonetheless higher doses (>0.3mg) were associated with more incidents of respiratory depression. In another study there was no evidence of respiratory depression following caesarean section under spinal anesthesia combined with morphine. Yet, in a prospective study that reviewed 856 cases of caesarean sections under spinal anesthesia combined with morphine a rate of 8 incidences of respiratory depression were found. In a retrospective study of 1915 cases of women undergoing caesarean section with spinal anesthesia combined with morphine a rate of 0.25% of respiratory depression was reported. The definition of respiratory depression is the lack of response to hypercapnia and/or hypoxia and it has been shown that intrathecal morphine depresses both responses. The common parameters that are monitored in order to detect respiratory depression include respiratory rate, sedation score, pulse oximetry, high PCo2 levels and the need for naloxone treatment. However, the overall measurement of frequency of respiratory depression postoperatively is variable. Accounting for this variability is the fact that hypercapnia may occur in patients with normal respiratory rate, normal sedation score and normal oxygen saturation. In addition, respiratory depression detected by high levels of PCo2 may be recognized earlier than with other parameters. The risk factors that were found to be associated with respiratory depression included high BMI, prior opioid use, magnesium infusion and respiratory comorbidities In a study of 856 women 8 of them experienced oxygen desaturation during sleep. All of these women were extremely obese with a prior history of deep snoring. In this study the investigators would like to examine whether there is a difference in the frequency of episodes of respiratory depression between obese (BMI≥30) and women with normal BMI receiving spinal anesthesia combined with intrathecal morphine during elective caesarean section. In previous studies it was reported that obese and non-obese women do not respond differently to modest doses of spinal anesthesia. Hence in this study the investigators can be certain that the investigators are examining the influence of addition of morphine to the spinal anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Depression
Keywords
Elective Caesarean Section, obese women, BMI≥30, spinal anesthesia combined with intrathecal morphine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
women BMI<30 POD 1
Arm Type
Active Comparator
Arm Description
Pregnant healthy women with BMI<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.
Arm Title
women BMI≥30 POD 1
Arm Type
Active Comparator
Arm Description
Pregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.
Arm Title
women BMI<30 POD4
Arm Type
Active Comparator
Arm Description
Pregnant healthy women with BMI<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.
Arm Title
women BMI≥30 POD 4
Arm Type
Active Comparator
Arm Description
Pregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.
Intervention Type
Device
Intervention Name(s)
SOMNOTOUCH RESP
Intervention Description
Ventilatory effort recorder
Intervention Type
Procedure
Intervention Name(s)
Caesarean section
Intervention Description
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
Intervention Type
Drug
Intervention Name(s)
Spinal anesthesia with intrathecal morphine
Other Intervention Name(s)
Subarachnoid block with intrathecal morphine, spinal block with intrathecal morphine
Intervention Description
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
Primary Outcome Measure Information:
Title
Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnancy Healthy women Exclusion Criteria: Heart diseases Autoimmune diseases Respiratory diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronnie Klein
Phone
+972-586972-195
Email
ronnie@ir-medical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaniv Cohen
Phone
+972-52-4677841
Email
yaniv@ir-medical.com
Facility Information:
Facility Name
Rambam healthcare campus
City
Haifa
State/Province
Isreal
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinat Lasker
Phone
+972-503312506
Email
r_laker@rmc.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section

We'll reach out to this number within 24 hrs