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

May 27, 2018 updated by: Rambam Health Care Campus

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Isreal
      • Haifa, Isreal, Israel
        • Recruiting
        • Rambam Healthcare Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy
  • Healthy women

Exclusion Criteria:

  • Heart diseases
  • Autoimmune diseases
  • Respiratory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: women BMI<30 POD 1
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.
Device: SOMNOTOUCH RESP
Ventilatory effort recorder
Procedure: Caesarean section
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
Drug: Spinal anesthesia with intrathecal morphine
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
Other Names:
  • Subarachnoid block with intrathecal morphine
  • spinal block with intrathecal morphine
ACTIVE_COMPARATOR: women BMI≥30 POD 1
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.
Device: SOMNOTOUCH RESP
Ventilatory effort recorder
Procedure: Caesarean section
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
Drug: Spinal anesthesia with intrathecal morphine
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
Other Names:
  • Subarachnoid block with intrathecal morphine
  • spinal block with intrathecal morphine
ACTIVE_COMPARATOR: women BMI<30 POD4
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.
Device: SOMNOTOUCH RESP
Ventilatory effort recorder
Procedure: Caesarean section
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
Drug: Spinal anesthesia with intrathecal morphine
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
Other Names:
  • Subarachnoid block with intrathecal morphine
  • spinal block with intrathecal morphine
ACTIVE_COMPARATOR: women BMI≥30 POD 4
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.
Device: SOMNOTOUCH RESP
Ventilatory effort recorder
Procedure: Caesarean section
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
Drug: Spinal anesthesia with intrathecal morphine
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
Other Names:
  • Subarachnoid block with intrathecal morphine
  • spinal block with intrathecal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 27, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0202-16-RMB CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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