Respiratory DepressionNCT02819661
Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section
A study testing SOMNOTOUCH RESP, Caesarean section and Spinal anesthesia with intrathecal morphine in people with Respiratory Depression, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- SOMNOTOUCH RESP, Caesarean section and Spinal anesthesia with intrathecal morphine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy
- Healthy women
Who cannot join
- Heart diseases
- Autoimmune diseases
- Respiratory diseases
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam healthcare campus
Haifa, Isreal
Rinat Lasker, +972-503312506, r_laker@rmc.gov.il
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Depression
- Being tested
- SOMNOTOUCH RESP, Caesarean section, Spinal anesthesia with intrathecal morphine
- Keywords
- Elective Caesarean Section, obese women, BMI≥30, spinal anesthesia combined with intrathecal morphine
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMNOTOUCH RESPDevice
Ventilatory effort recorder
Caesarean sectionProcedure or surgery
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
Spinal anesthesia with intrathecal morphineDrug
Also called Subarachnoid block with intrathecal morphine, spinal block with intrathecal morphine
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
| Study group | Role | What they receive |
|---|---|---|
| women BMI<30 POD 1 | Active comparator | 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. Receives: Device: SOMNOTOUCH RESP; Procedure: Caesarean section; Drug: Spinal anesthesia with intrathecal morphine |
| women BMI≥30 POD 1 | Active comparator | 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. Receives: Device: SOMNOTOUCH RESP; Procedure: Caesarean section; Drug: Spinal anesthesia with intrathecal morphine |
| women BMI<30 POD4 | Active comparator | 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. Receives: Device: SOMNOTOUCH RESP; Procedure: Caesarean section; Drug: Spinal anesthesia with intrathecal morphine |
| women BMI≥30 POD 4 | Active comparator | 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. Receives: Device: SOMNOTOUCH RESP; Procedure: Caesarean section; Drug: Spinal anesthesia with intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start1 May 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819661
- Sponsor's protocol ID
- 0202-16-RMB CTIL
- Status last verified
- May 2018
- First submitted
- 15 Jun 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02819661
- Acronym / sponsor ID
- 0202-16-RMB CTIL
- Conditions
- Respiratory Depression
- Keywords
- Elective Caesarean Section, obese women, BMI≥30, spinal anesthesia combined with intrathecal morphine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| women BMI<30 POD 1 | Active comparator | Device: SOMNOTOUCH RESP, Procedure: Caesarean section, Drug: Spinal anesthesia with intrathecal morphinePregnant 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. |
| women BMI≥30 POD 1 | Active comparator | Device: SOMNOTOUCH RESP, Procedure: Caesarean section, Drug: Spinal anesthesia with intrathecal morphinePregnant 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. |
| women BMI<30 POD4 | Active comparator | Device: SOMNOTOUCH RESP, Procedure: Caesarean section, Drug: Spinal anesthesia with intrathecal morphinePregnant 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. |
| women BMI≥30 POD 4 | Active comparator | Device: SOMNOTOUCH RESP, Procedure: Caesarean section, Drug: Spinal anesthesia with intrathecal morphinePregnant 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnancy
- Healthy women
Key exclusion criteria (3 listed)
- Heart diseases
- Autoimmune diseases
- Respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOMNOTOUCH RESPVentilatory effort recorder | Device | women BMI<30 POD 1, women BMI<30 POD4, women BMI≥30 POD 1, women BMI≥30 POD 4 |
| Caesarean sectionCesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy). | Procedure or surgery | women BMI<30 POD 1, women BMI<30 POD4, women BMI≥30 POD 1, women BMI≥30 POD 4 |
| Spinal anesthesia with intrathecal morphineAlso: Subarachnoid block with intrathecal morphine, spinal block with intrathecal morphineis a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space | Drug | women BMI<30 POD 1, women BMI<30 POD4, women BMI≥30 POD 1, women BMI≥30 POD 4 |
Primary outcome
Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOMNOTOUCH RESP, Caesarean section and Spinal anesthesia with intrathecal morphine in people with Respiratory Depression, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronnie Klein (+972-586972-195, ronnie@ir-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.