Respiratory Depression Clinical Trial
Official title:
Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids: a Comparison Between Diamorphine and Fentanyl Combined With Postoperative Morphine PCA Using a Carbon Dioxide Tension and Pulse Oximetry Sensor (TOSCA)
Verified date | February 2009 |
Source | NHS Greater Clyde and Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Observational |
Spinal Administration of opioids offers segmental analgesia, but has side effects including pruritus, nausea and vomiting, urinary retention, hypotension, and respiratory depression, both early and delayed. Many Centres in the UK now routinely use supplementation of spinal anaesthesia from bupivacaine with intrathecal fentanyl or diamorphine. If Fentanyl is used, this is usually accompanied by connection to a i.v. Morphine patient-controlled analgesia (PCA)-device in the postoperative period, whereas the use of intrathecal diamorphine seems to result in a reduction in post-operative morphine requirements, which has obviated the need for PCA devices in many centres. There has been recent controversy over which opioid is safer to use with regards to the risk of respiratory depression.1,2 The investigators want to investigate, whether intrathecal diamorphine causes less or more post-operative respiratory depression in healthy mothers undergoing elective caesarean section than intrathecal fentanyl plus post-operative morphine PCA.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 1st patient on list - ASA I or II - BMI <40 at booking - Term pregnancy +/- 2 weeks gestation Exclusion Criteria: - ASA>II - BMI>40 at booking - History of Obstructive Sleep Apnoea (OSA) - Need for supplementation with intravenous Opioids intraoperatively - Conversion to GA |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Princess Royal Maternity Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Clyde and Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | transcutaneous carbon dioxide tension | within the first 24 hours after surgery | Yes | |
Secondary | oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management | within first 24 hours after surgery | Yes |
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