Cesarean DeliveryATOCEBNCT00815022
Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia
A study testing bupivacaine/fentanyl/morphine in people with Cesarean Delivery, run by Nanjing Medical University at 1 site in China.
Trial summary
Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- bupivacaine/fentanyl/morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2012
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women
- > 18 years and < 45 years
Who cannot join
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years or older than 45 years
- Those who were not willing to or could not finish the whole study at any time
- Alcohol addictive or narcotic dependent patients
- Subjects with a nonvertex presentation
- Diagnosed diabetes mellitus and pregnancy-induced hypertension
- Twin gestation and breech presentation
- Pregnant fever
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery
Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.
- Conditions
- Cesarean Delivery
- Being tested
- bupivacaine/fentanyl/morphine
- Keywords
- Temperature, Spinal anesthesia, Cesarean section, Cephalad sensory blockade, Regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine/fentanyl/morphineDrug
Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius Receives: Drug: bupivacaine/fentanyl/morphine |
| 2 | Experimental | Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius Receives: Drug: bupivacaine/fentanyl/morphine |
| 3 | Experimental | Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius Receives: Drug: bupivacaine/fentanyl/morphine |
| 4 | Experimental | Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius Receives: Drug: bupivacaine/fentanyl/morphine |
| 5 | Experimental | Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius Receives: Drug: bupivacaine/fentanyl/morphine |
| 6 | Experimental | Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius Receives: Drug: bupivacaine/fentanyl/morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum cephalad sensory blockade to pinprick, cold and touch
Measured: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
Secondary outcomes (3)
Velocity of the sensory blockade at identical body position
Measured: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
The total dose of phenylephrine required to maintain baseline arterial blood pressure
Measured: From the delivery of anesthetic mixture to 25 min after spinal anesthesia
Time interval of the occurrence of the hypotension
Measured: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Zhou Wang, Nanjing Medical University
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815022
- Sponsor's protocol ID
- NMU-200812-MZ32
- Other IDs
- NJFY0812009
- Acronym
- ATOCEB
- Status last verified
- Jan 2014
- First submitted
- 26 Dec 2008
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT00815022
- Acronym / sponsor ID
- ATOCEB / NMU-200812-MZ32
- Conditions
- Cesarean Delivery
- Keywords
- Temperature, Spinal anesthesia, Cesarean section, Cephalad sensory blockade, Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Dec 2008 (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.
Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: bupivacaine/fentanyl/morphineMixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius |
| 2 | Experimental | Drug: bupivacaine/fentanyl/morphineMixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius |
| 3 | Experimental | Drug: bupivacaine/fentanyl/morphineMixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius |
| 4 | Experimental | Drug: bupivacaine/fentanyl/morphineMixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius |
| 5 | Experimental | Drug: bupivacaine/fentanyl/morphineMixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius |
| 6 | Experimental | Drug: bupivacaine/fentanyl/morphineMixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nulliparous women
- > 18 years and < 45 years
Key exclusion criteria (8 listed)
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years or older than 45 years
- Those who were not willing to or could not finish the whole study at any time
- Alcohol addictive or narcotic dependent patients
- Subjects with a nonvertex presentation
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 |
|---|---|---|
| bupivacaine/fentanyl/morphineHyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Maximum cephalad sensory blockade to pinprick, cold and touch
Time frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
3 secondary outcomes
Velocity of the sensory blockade at identical body position
Time frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
The total dose of phenylephrine required to maintain baseline arterial blood pressure
Time frame: From the delivery of anesthetic mixture to 25 min after spinal anesthesia
Time interval of the occurrence of the hypotension
Time frame: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine/fentanyl/morphine in people with Cesarean Delivery, run by Nanjing Medical University at 1 site in China.
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 8 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: finished, as of the sponsor's last update on 14 Jan 2014. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum cephalad sensory blockade to pinprick, cold and touch (time frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia). 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 14 Jan 2014.