AnesthesiaPhase 4NCT06060015
Effect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean Section
A Phase 4 study testing 5mg bupivacaine and 10mg bupivacaine in people with Anesthesia and Obstetric Anesthesia Problems, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
Evaluates the effect of hyperbaric subarachnoid bupivacaine at doses of 5 mg vs 10 mg on mean arterial pressure in obese pregnant patients undergoing cesarean section Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia, Obstetric Anesthesia Problems
- What is being tested?
- 5mg bupivacaine and 10mg bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy ≥37 weeks gestation with single fetus
- Body mass index (BMI) ≥ 30 kg/m2
- Indication of termination of pregnancy via abdominal caesarean section
- Indication of subarachnoid neuraxial block under mixed technique
- Signing of consent under information
Who cannot join
- Allergy to local anesthetics
- Psychiatric treatment (antidepressants, anxiolytics, antipsychotics)
- Addiction to any type of drug
- Liver, renal, pulmonary or cardiac disease
- High blood pressure
- Type I, II and gestational diabetes
- Diagnostic of non-calming fetal state
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44280
MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, MSc, +5213310233983 ext. 3310233983, angelescampechano@hotmail.com
MIRIAM MENDEZ DEL VILLAR, MSc PhD, +5213310640220, miriamendez@hotmail.com
About this study
Official title: Effect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section
Evaluates the effect of hyperbaric subarachnoid bupivacaine at doses of 5 mg vs 10 mg on mean arterial pressure in obese pregnant patients undergoing cesarean section
Read the detailed description
Patients over 18 years of age, with a pregnancy of ≥37 weeks of gestation and adequate fetal well-being, with obesity with a BMI ≥30 kg/m2 presented for cesarean surgery will be included in the study. The objectives of the study protocol, benefits, and benefits will be explained to them. and risks and by election by sealed envelope will be assigned to one of the two study groups, they will be given to sign the consent letter under information. They underwent pre-anesthetic evaluation, baseline vital signs: non-invasive blood pressure, mean arterial pressure (MAP), O2 saturation and heart rate, fetal heart rate will be recorded from the fetal monitor. A preload of Hartmann's solution fluids at 10ml/kg of pre-pregnancy weight and premedication with omeprazole 40mg and metoclopramide 10mg will be administered. Once inside the operating room, baseline vital signs will be recorded and the placement of anesthesia with mixed technique neuraxial block (epidural catheter placement + subarachnoid block) will begin in a sitting position, the anatomical reference of the intervertebral space L2-L3, L3- will be located. L4. The aseptic and antiseptic technique with povidone-iodine and alcohol will be performed on the skin, sterile fields will be placed, the skin and subcutaneous tissue will be infiltrated with 5 ml of 2% lidocaine, a Tuohy No. 17 needle is inserted with the "hanging Drop" technique, to locate the epidural space, it was corroborated with the "loss of resistance" technique. Through the "Tuohy needle", the "spinal needle" No. 27 spinal needle is inserted until cerebrospinal fluid (CSF) is obtained. The blocking dose of hyperbaric bupivacaine of 10 mg (2 ml) or mg (1 ml) will be administered according to the assigned group; The "spinal needle" was withdrawn and the epidural catheter was inserted in a cephalic direction, leaving 5 cm inside the epidural space. The catheter was fixed to the skin with adhesive tape for later use. The patient will be placed in the supine position and a position is given with the surgical table 30 degrees to the left. Vital sign monitoring was started every 3 minutes for the first 15 minutes and then every 5 minutes until the end of the procedure. When a MAP record of less than 20% is obtained at the beginning, 10 mg ephedrine will be administered, an evaluation of the sensory block will begin 6 minutes after administering the block dose, with the prick technique, this evaluation will be It will be performed every 3 minutes during the first 15 minutes and then every 15 minutes until the end of the surgery. Simultaneously, an assessment of motor blockade will begin with a Bromage scale. After taking the second vital signs (3 minutes), the patient will be asked if she feels nauseated or if she vomits and it will be recorded. At the time of the extraction of the fetus, the Apgar score given by the neonatologist at one minute and at 5 minutes of extrauterine life will be recorded. Once the placenta has been delivered, a sample for gasometry will be taken with a heparinized syringe from the umbilical artery and sent to the laboratory for processing. A dose of local anesthetic will be administered through a 5% to 2% lidocaine epidural catheter if the patient reports discomfort or pain and the surgical procedure has not been completed. The information collected will be recorded in the data collection sheet. The sample size was calculated with a formula for comparing two means with a finite population.A pilot test was carried out with the specified criteria, which included 40 patients, 20 patients received 5 mg of subarachnoid hyperbaric bupivacaine and 20 patients received 10 mg, for the maximum arterial hypotension variable registered a standard deviation of 16.87 was obtained. The finite population was obtained by registering the total cesarean sections of the Civil Hospital of Guadalajara performed during the year 2022, which were 1,256 cesarean sections and losses of 20% are calculated, obtaining a total of 53 patients per group with a total of 106 patients. Once the sample is completed, the database will be started in the Microsoft Office Excel program, which will be exported to the statistical program Statistics Product and Service Solution (SPSS) for statistical analysis. The data obtained will be expressed through measures of central tendency and dispersion, mean, minimum, maximum, median and standard deviation for quantitative variables, and frequencies and percentages in the case of qualitative variables. The intragroup differences for the quantitative variables were performed using the Student's T test, differences between the groups were determined with the U Mann Whitney test. Qualitative variables will be analyzed with the Chi Square test. A value of p≤0.05 is considered statistically significant.
- Conditions
- Anesthesia, Obstetric Anesthesia Problems
- Being tested
- 5mg bupivacaine, 10mg bupivacaine
- Keywords
- Anesthesia, Obesity, Cesarean, Subarachnoid, Bupivacaine, pregnancy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg bupivacaineDrug
Also called hyperbaric bupivacaine 1ml, bupivacaine/Dextrose 1ml
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg
10mg bupivacaineDrug
Also called hyperbaric bupivacaine 2ml, bupivacaine/Dextrose 2ml
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10 mg
| Study group | Role | What they receive |
|---|---|---|
| 5mg bupivacaine | Experimental | Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg Receives: Drug: 5mg bupivacaine |
| 10mg bupivacaine | Experimental | Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10mg Receives: Drug: 10mg bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the mean blood pressure
Number of pregnant patients with obesity who present a decrease in mean arterial pressure after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery
Measured: 3 hour
Determine the effects on the heart rate
Number of pregnant patients with obesity who present changes in heart rate such as bradycardia (heart rate less than 60 beats minute) or tachycardia (heart rate greater than 120 beats minute) after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery
Measured: 3 hour
Determine the effects on the O2 saturation
Number of pregnant patients with obesity who present changes in O2 saturation after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery
Measured: 3 hour
Secondary outcomes (4)
Describe the adverse effects (nausea or vomiting)
Number of pregnant patients with obesity with side effects such as nausea or vomiting after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery
Measured: 3 hour
Identify the level of sensory blockade
Number of pregnant patients with obesity with adequate sensory block (thoracic dermatome 4 is defined as adequate to begin the surgical technique), the level of sensory block reached after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg. The sensory block was evaluated using pinprick. Every 3 minutes the first 15 minutes after the subarachnoid block.
Measured: 15 minutes
Describe the adverse effects on the fetus
Number of pregnant patients with obesity with any side effect associated with the fetal bradycardia anesthetic technique (Fetal heart rate less than 120 beats minute) cardiac arrest (Fetal heart rate less than 100 beats minute) And in the newborn fetal acidosis (umbilical vein gasometry with Hydrogen Potential (pH) <7.0 or excess bases >-12 mmol/L)
Measured: 1 hour
Document the Apgar score
Document the Apgar score in the newborn. (Apgar Score evaluate five sign: color, heart rate, reflex irritability, muscle tone and respiration) The score ranges from 0 to 2 per sign according to the criteria of the neonatologist, to grant a maximum score of 10 points. A grade of less than 7 points is considered low Apgar scores. This scores is registered t minute and five minutes of life.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Aug 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial open controlled parallel randomized simple
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María de los Angeles Campechano Ascencio, Hospital Civil de Guadalajara
- Investigators
- María de los Angeles Campechano Ascencio, MSc, Principal investigator, Hospital Civil de GuadalajaraMiriam Mendez del Villar, PhD, Study director, Universidad de Guadalajara Centro Universitario de TonaláLeonel Garcia Benavides, PhD, Study chair, Universidad de Guadalajara Centro Universitario de TonaláJorge Bravo Rubio, MSc, Study chair, Hospital Civil de GuadalajaraEdy David Rubio Arellano, MSc, Study chair, Universidad de Guadalajara Centro Universitario Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060015
- Sponsor's protocol ID
- 168/23
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eltzschig HK, Lieberman ES, Camann WR. Regional anesthesia and analgesia for labor and delivery. N Engl J Med. 2003 Jan 23;348(4):319-32. doi: 10.1056/NEJMra021276. No abstract available.
PubMed 12540646Badve MH, Golfeiz C, Vallejo MC. Anesthetic considerations for the morbid obese parturient. Int Anesthesiol Clin. 2014 Summer;52(3):132-47. doi: 10.1097/AIA.0000000000000024. No abstract available.
PubMed 24946047Tonidandel A, Booth J, D'Angelo R, Harris L, Tonidandel S. Anesthetic and obstetric outcomes in morbidly obese parturients: a 20-year follow-up retrospective cohort study. Int J Obstet Anesth. 2014 Nov;23(4):357-64. doi: 10.1016/j.ijoa.2014.05.004. Epub 2014 Jun 4.
PubMed 25201313Ouzounian JG, Elkayam U. Physiologic changes during normal pregnancy and delivery. Cardiol Clin. 2012 Aug;30(3):317-29. doi: 10.1016/j.ccl.2012.05.004. Epub 2012 Jun 20.
PubMed 22813360Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
PubMed 8267196Tan T, Sia AT. Anesthesia considerations in the obese gravida. Semin Perinatol. 2011 Dec;35(6):350-5. doi: 10.1053/j.semperi.2011.05.021.
PubMed 22108086Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.
PubMed 19672175Lee Y, Balki M, Parkes R, Carvalho JC. Dose requirement of intrathecal bupivacaine for cesarean delivery is similar in obese and normal weight women. Rev Bras Anestesiol. 2009 Nov-Dec;59(6):674-83. doi: 10.1016/s0034-7094(09)70092-3. English, Portuguese.
PubMed 20011857Carvalho B, Collins J, Drover DR, Atkinson Ralls L, Riley ET. ED(50) and ED(95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery. Anesthesiology. 2011 Mar;114(3):529-35. doi: 10.1097/ALN.0b013e318209a92d.
PubMed 21307769Reyes M, Pan PH. Very low-dose spinal anesthesia for cesarean section in a morbidly obese preeclamptic patient and its potential implications. Int J Obstet Anesth. 2004 Apr;13(2):99-102. doi: 10.1016/j.ijoa.2003.09.004.
PubMed 15321413Teoh WH, Thomas E, Tan HM. Ultra-low dose combined spinal-epidural anesthesia with intrathecal bupivacaine 3.75 mg for cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2006 Oct;15(4):273-8. doi: 10.1016/j.ijoa.2006.03.004. Epub 2006 Jun 13.
PubMed 16774830Bamgbade OA, Khalaf WM, Ajai O, Sharma R, Chidambaram V, Madhavan G. Obstetric anaesthesia outcome in obese and non-obese parturients undergoing caesarean delivery: an observational study. Int J Obstet Anesth. 2009 Jul;18(3):221-5. doi: 10.1016/j.ijoa.2008.07.013. Epub 2009 May 17.
PubMed 19447599Nani FS, Torres ML. Correlation between the body mass index (BMI) of pregnant women and the development of hypotension after spinal anesthesia for cesarean section. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):21-30. doi: 10.1016/S0034-7094(11)70003-4.
PubMed 21334504Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.
PubMed 27870737Hassanin AS, El-Shahawy HF, Hussain SH, Bahaa Eldin AM, Elhawary MM, Elbakery M, Elsafty MSE. Impact of interval between induction of spinal anesthesia to delivery on umbilical arterial cord ph of neonates delivered by elective cesarean section. BMC Pregnancy Childbirth. 2022 Mar 17;22(1):216. doi: 10.1186/s12884-022-04536-y.
PubMed 35300620
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT06060015
- Acronym / sponsor ID
- 168/23
- Conditions
- Anesthesia, Obstetric Anesthesia Problems
- Keywords
- Anesthesia, Obesity, Cesarean, Subarachnoid, Bupivacaine, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- 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.
Evaluates the effect of hyperbaric subarachnoid bupivacaine at doses of 5 mg vs 10 mg on mean arterial pressure in obese pregnant patients undergoing cesarean section
Detailed description
Patients over 18 years of age, with a pregnancy of ≥37 weeks of gestation and adequate fetal well-being, with obesity with a BMI ≥30 kg/m2 presented for cesarean surgery will be included in the study. The objectives of the study protocol, benefits, and benefits will be explained to them. and risks and by election by sealed envelope will be assigned to one of the two study groups, they will be given to sign the consent letter under information. They underwent pre-anesthetic evaluation, baseline vital signs: non-invasive blood pressure, mean arterial pressure (MAP), O2 saturation and heart rate, fetal heart rate will be recorded from the fetal monitor. A preload of Hartmann's solution fluids at 10ml/kg of pre-pregnancy weight and premedication with omeprazole 40mg and metoclopramide 10mg will be administered. Once inside the operating room, baseline vital signs will be recorded and the placement of anesthesia with mixed technique neuraxial block (epidural catheter placement + subarachnoid block) will begin in a sitting position, the anatomical reference of the intervertebral space L2-L3, L3- will be located. L4. The aseptic and antiseptic technique with povidone-iodine and alcohol will be performed on the skin, sterile fields will be placed, the skin and subcutaneous tissue will be infiltrated with 5 ml of 2% lidocaine, a Tuohy No. 17 needle is inserted with the "hanging Drop" technique, to locate the epidural space, it was corroborated with the "loss of resistance" technique. Through the "Tuohy needle", the "spinal needle" No. 27 spinal needle is inserted until cerebrospinal fluid (CSF) is obtained. The blocking dose of hyperbaric bupivacaine of 10 mg (2 ml) or mg (1 ml) will be administered according to the assigned group; The "spinal needle" was withdrawn and the epidural catheter was inserted in a cephalic direction, leaving 5 cm inside the epidural space. The catheter was fixed to the skin with adhesive tape for later use. The patient will be placed in the supine position and a position is given with the surgical table 30 degrees to the left. Vital sign monitoring was started every 3 minutes for the first 15 minutes and then every 5 minutes until the end of the procedure. When a MAP record of less than 20% is obtained at the beginning, 10 mg ephedrine will be administered, an evaluation of the sensory block will begin 6 minutes after administering the block dose, with the prick technique, this evaluation will be It will be performed every 3 minutes during the first 15 minutes and then every 15 minutes until the end of the surgery. Simultaneously, an assessment of motor blockade will begin with a Bromage scale. After taking the second vital signs (3 minutes), the patient will be asked if she feels nauseated or if she vomits and it will be recorded. At the time of the extraction of the fetus, the Apgar score given by the neonatologist at one minute and at 5 minutes of extrauterine life will be recorded. Once the placenta has been delivered, a sample for gasometry will be taken with a heparinized syringe from the umbilical artery and sent to the laboratory for processing. A dose of local anesthetic will be administered through a 5% to 2% lidocaine epidural catheter if the patient reports discomfort or pain and the surgical procedure has not been completed. The information collected will be recorded in the data collection sheet. The sample size was calculated with a formula for comparing two means with a finite population.A pilot test was carried out with the specified criteria, which included 40 patients, 20 patients received 5 mg of subarachnoid hyperbaric bupivacaine and 20 patients received 10 mg, for the maximum arterial hypotension variable registered a standard deviation of 16.87 was obtained. The finite population was obtained by registering the total cesarean sections of the Civil Hospital of Guadalajara performed during the year 2022, which were 1,256 cesarean sections and losses of 20% are calculated, obtaining a total of 53 patients per group with a total of 106 patients. Once the sample is completed, the database will be started in the Microsoft Office Excel program, which will be exported to the statistical program Statistics Product and Service Solution (SPSS) for statistical analysis. The data obtained will be expressed through measures of central tendency and dispersion, mean, minimum, maximum, median and standard deviation for quantitative variables, and frequencies and percentages in the case of qualitative variables. The intragroup differences for the quantitative variables were performed using the Student's T test, differences between the groups were determined with the U Mann Whitney test. Qualitative variables will be analyzed with the Chi Square test. A value of p≤0.05 is considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial open controlled parallel randomized simple
| Arm | Type | Receives |
|---|---|---|
| 5mg bupivacaine | Experimental | Drug: 5mg bupivacaineAnesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg |
| 10mg bupivacaine | Experimental | Drug: 10mg bupivacaineAnesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnancy ≥37 weeks gestation with single fetus
- Body mass index (BMI) ≥ 30 kg/m2
- Indication of termination of pregnancy via abdominal caesarean section
- Indication of subarachnoid neuraxial block under mixed technique
- Signing of consent under information
Key exclusion criteria (7 listed)
- Allergy to local anesthetics
- Psychiatric treatment (antidepressants, anxiolytics, antipsychotics)
- Addiction to any type of drug
- Liver, renal, pulmonary or cardiac disease
- High blood pressure
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 |
|---|---|---|
| 5mg bupivacaineAlso: hyperbaric bupivacaine 1ml, bupivacaine/Dextrose 1mlAnesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg | Drug | 5mg bupivacaine |
| 10mg bupivacaineAlso: hyperbaric bupivacaine 2ml, bupivacaine/Dextrose 2mlAnesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10 mg | Drug | 10mg bupivacaine |
Primary outcome
Assess the mean blood pressure
Time frame: 3 hour
Number of pregnant patients with obesity who present a decrease in mean arterial pressure after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery
Determine the effects on the heart rate
Time frame: 3 hour
Number of pregnant patients with obesity who present changes in heart rate such as bradycardia (heart rate less than 60 beats minute) or tachycardia (heart rate greater than 120 beats minute) after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery
Determine the effects on the O2 saturation
Time frame: 3 hour
Number of pregnant patients with obesity who present changes in O2 saturation after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery
4 secondary outcomes
Describe the adverse effects (nausea or vomiting)
Time frame: 3 hour
Identify the level of sensory blockade
Time frame: 15 minutes
Describe the adverse effects on the fetus
Time frame: 1 hour
Document the Apgar score
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 12540646Eltzschig HK, Lieberman ES, Camann WR. Regional anesthesia and analgesia for labor and delivery. N Engl J Med. 2003 Jan 23;348(4):319-32. doi: 10.1056/NEJMra021276. No abstract available.
- Results publication: PubMed 24946047Badve MH, Golfeiz C, Vallejo MC. Anesthetic considerations for the morbid obese parturient. Int Anesthesiol Clin. 2014 Summer;52(3):132-47. doi: 10.1097/AIA.0000000000000024. No abstract available.
- Results publication: PubMed 25201313Tonidandel A, Booth J, D'Angelo R, Harris L, Tonidandel S. Anesthetic and obstetric outcomes in morbidly obese parturients: a 20-year follow-up retrospective cohort study. Int J Obstet Anesth. 2014 Nov;23(4):357-64. doi: 10.1016/j.ijoa.2014.05.004. Epub 2014 Jun 4.
- Results publication: PubMed 22813360Ouzounian JG, Elkayam U. Physiologic changes during normal pregnancy and delivery. Cardiol Clin. 2012 Aug;30(3):317-29. doi: 10.1016/j.ccl.2012.05.004. Epub 2012 Jun 20.
- Results publication: PubMed 8267196Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
- Results publication: PubMed 22108086Tan T, Sia AT. Anesthesia considerations in the obese gravida. Semin Perinatol. 2011 Dec;35(6):350-5. doi: 10.1053/j.semperi.2011.05.021.
- Results publication: PubMed 19672175Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.
- Results publication: PubMed 20011857Lee Y, Balki M, Parkes R, Carvalho JC. Dose requirement of intrathecal bupivacaine for cesarean delivery is similar in obese and normal weight women. Rev Bras Anestesiol. 2009 Nov-Dec;59(6):674-83. doi: 10.1016/s0034-7094(09)70092-3. English, Portuguese.
- Results publication: PubMed 21307769Carvalho B, Collins J, Drover DR, Atkinson Ralls L, Riley ET. ED(50) and ED(95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery. Anesthesiology. 2011 Mar;114(3):529-35. doi: 10.1097/ALN.0b013e318209a92d.
- Results publication: PubMed 15321413Reyes M, Pan PH. Very low-dose spinal anesthesia for cesarean section in a morbidly obese preeclamptic patient and its potential implications. Int J Obstet Anesth. 2004 Apr;13(2):99-102. doi: 10.1016/j.ijoa.2003.09.004.
- Results publication: PubMed 16774830Teoh WH, Thomas E, Tan HM. Ultra-low dose combined spinal-epidural anesthesia with intrathecal bupivacaine 3.75 mg for cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2006 Oct;15(4):273-8. doi: 10.1016/j.ijoa.2006.03.004. Epub 2006 Jun 13.
- Results publication: PubMed 19447599Bamgbade OA, Khalaf WM, Ajai O, Sharma R, Chidambaram V, Madhavan G. Obstetric anaesthesia outcome in obese and non-obese parturients undergoing caesarean delivery: an observational study. Int J Obstet Anesth. 2009 Jul;18(3):221-5. doi: 10.1016/j.ijoa.2008.07.013. Epub 2009 May 17.
- World Health Organization. Obesity and Overweight Descriptive note No 311.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
María de los Angeles Campechano Ascencio, MSc principal investigator
Hospital Civil de Guadalajara
Miriam Mendez del Villar, PhD study director
Universidad de Guadalajara Centro Universitario de Tonalá
Leonel Garcia Benavides, PhD study chair
Universidad de Guadalajara Centro Universitario de Tonalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5mg bupivacaine and 10mg bupivacaine in people with Anesthesia and Obstetric Anesthesia Problems, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 5 inclusion and 7 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 29 Sep 2023. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 María de los Angeles Campechano Ascencio, MSc (+5213310233983, angelescampechano@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the mean blood pressure (time frame: 3 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060015, which also lists 39 linked publications.
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 29 Sep 2023.