Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids for Caesarean Section
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Respiratory Depression |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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) |
- transcutaneous carbon dioxide tension [ Time Frame: within the first 24 hours after surgery ] [ Designated as safety issue: Yes ]
- oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management [ Time Frame: within first 24 hours after surgery ] [ Designated as safety issue: Yes ]
| Enrollment: | 90 |
| Study Start Date: | October 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
D, F
Group D will be patients at Princess Royal Maternity Hospital in Glasgow, where supplementation with intrathecal diamorphine 300mcg is the current anaesthetic technique of choice. Group F will be patients at the Queen Mother's Maternity Hospital in Glasgow, where supplementation with intrathecal fentanyl 15mcg plus post-operative morphine PCA is the current anaesthetic technique of choice for elective caesarean section. |
Show Detailed Description
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Elective caesarean section Healthy pregnant women
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
Contacts and Locations| United Kingdom | |
| Princess Royal Maternity Hospital | |
| Glasgow, United Kingdom, G4 0SF | |
| Principal Investigator: | Stephan Dalchow, FRCA | National Health Service |
More Information
No publications provided
| Responsible Party: | Dr Stephan Dalchow, NHS Greater Clyde&Glasgow |
| ClinicalTrials.gov Identifier: | NCT00544947 History of Changes |
| Other Study ID Numbers: | 07/S0704/67 |
| Study First Received: | October 12, 2007 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by NHS Greater Clyde and Glasgow:
|
Respiratory Depression Caesarean Section Diamorphine Fentanyl |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Respiratory Insufficiency Behavioral Symptoms Mood Disorders Mental Disorders Respiration Disorders Respiratory Tract Diseases Anesthetics Fentanyl Heroin Analgesics, Opioid |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on May 23, 2013