ObesityNCT04612998
Combined Spinal Epidural Anesthesia in Obese Patients Undergoing Cesarean Surgery
A study testing left lateral decubitus position, sitting position and The use of intravenous ephedrine. in people with Obesity and Pregnancy Related, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the maternal and fetal effects during performance of CSEA in the left lateral decubitus and sitting positions in obese pregnant women undergoing elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pregnancy Related, Cesarean Section Complications
- What is being tested?
- left lateral decubitus position, sitting position and The use of intravenous ephedrine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 5 Apr 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- obese women with full-term gestation
- aged between 18-45 years
- ASA (American society of anesthesiologist) I and II
- undergoing elective cesarean section with combined spinal-epidural anesthesia
Who cannot join
- psychiatric diseases
- preeclampsia
- pregnancy-induced hypertension
- chronic hypertension
- diabetes
- multiple pregnancies
- fetal anomaly
- allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Spinal Epidural Anesthesia in Obese Patients Undergoing Cesarean Surgery: A Randomised Comparison of Lateral Decubitus and Sitting Positions
This study investigated the maternal and fetal effects during performance of CSEA in the left lateral decubitus and sitting positions in obese pregnant women undergoing elective cesarean section.
Read the detailed description
The study population comprised 100 pregnant women diagnosed with obese aged between 18-45 years, American society of anesthesiologist I and II with full-term gestation undergoing elective cesarean section under combined spinal - epidural anesthesia (CSEA). Women with psychiatric diseases, preeclampsia, pregnancy-induced hypertension or chronic hypertension, diabetes, multiple pregnancies, fetal anomaly and allergy to study drugs were excluded from the study. Also, patients requiring general anesthesia and patients with an average blood pressure below 90 and heart rate less than 50 were excluded. Before performance of CSEA, two groups were formed by randomization. A computer-generated table of random numbers was used for randomization. The CESA was performed in left lateral position in Group I (n=50) and in sitting position in Group II (n=50).
Premedication was not performed in any patient. Before entering the operating room, 10 mL/kg lactated Ringer's solution was given to all patients via IV cannula over 20 minutes. Standard monitoring was performed in the operating room. Before the operation; patients' age, weight, height, ASA physical status and basal hemodynamic parameters were recorded. The CSEA was planned for all patients. All interventions were performed by an experienced anesthesiologist. Patients were appropriately positioned in accordance with the group in which they were included. Group I (n=50) consisted of patients performing CSEA in the left lateral decubitus position. The patient was laid on her left side, the legs were flexed on the abdomen and the chin on the chest. Group II (n=50) consisted of patients performing CSEA in the sitting position. The patient was seated on the edge of the operating table with his feet hanging down, the feet supported by a chair, a pillow was given on her lap, and the patient clung to the pillow. After the skin was sterilized and local infiltration was performed with 2% lidocaine, 18 gauge Tuohy needle (Set for CSEA, Braun®, Melsungen, Germany) was advanced through the midline L2-3 or L3-4 intervertebral spaces with loss of resistance technique. Intrathecally, a 27-gauge pencil point needle was inserted using the needle-through-needle technique. When free cerebrospinal fluid flow was seen, 1.8 ml 0.5% isobaric bupivacaine (9 mg) was administered over 30 seconds. The epidural catheter was advanced 3 cm into the epidural space following the spinal needle was removed. After the catheter was checked with negative pressure, it was secured in place. At the end of the procedure patients were placed in the supine position for operation and the operating table was tilted 20° to the left. Sensory block level was evaluated via pinprick test and it was recorded bilaterally every two minutes. Surgery was initiated following the sensory block reached at the upper level of T6 dermatome. If signs of analgesia were not observed within the first 20 min following the spinal injection, spinal anesthesia was evaluated as failed. In case of failure, additional 5 ml solution of 2% lidocaine was performed via the epidural catheter (5-min intervals, the total dose of 15 mg) until a T6 level of the sensory block was provided. Motor block level was evaluated with Modified Bromage scale (scale 0 = motor block is not available; scale 1 = The patient can do the full flexion of foot and knee, she is unable to hip flexion; scale 2 = The patient can do the full flexion of foot, she is unable to knee and hip flexion; scale 3 = Total motor block is available). General anaesthesia protocol was applied in case of three unsuccessful attempts to reach to intrathecal space. Oxygen was delivered during surgery. Intravenous ephedrine (6 mg) was used to treat hypotension (a 30% decrease in systolic blood pressure compared to preoperative values) during surgery. Intra-venous atropine (1 mg) was given in case of bradycardia (the heart rate < 45 beats/minute) during surgery. When nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered. The application time of the CSEA, the time from the spinal injection to the development of sensory blockade up to T6 dermatome, operation time (the time from the start of the surgical incision until the end of surgery), highest sensory block level, anesthetic complications and the number of patients required epidural medication during surgery were recorded. Following drug administration to the intrathecal space, intraoperative hemodynamic changes were recorded every 2 min. After surgery was initiated, hemodynamic changes were recorded in 5-minute intervals until the end of the operation. Side effects such as pruritus and nausea, the number of patients requiring ephedrine, atropine or analgesic were recorded. After delivery, 30 IU oxytocin in 500 mL Ringer's lactate solution was given intravenously. Neonatal Apgar scores obtained at 1 and 5 min after delivery and umbilical artery blood gas values were recorded.
After surgery, patients were followed in the recovery room for 120 min. In the recovery room, Visual analogue scale (VAS, 0 cm= no pain, 10 cm= worst pain) scores for pain severity, anesthesia-related side effects (e.g., nausea, vomiting and headache), sensory block time (from the spinal injection to the recovery of T10 dermatome), and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively. In the case of VAS > 3 in a patient, 5 ml solution of 2% lidocaine was given through the epidural catheter. When the motor block had regressed to the T10 level, patients were sent to the clinics.Sample size was calculated as minimum 40 patients in each group, based on data obtained in previous studies, to detect a minimum difference in the requirement of 10 mg ephedrine between the two groups with a power of 90%, a of 0.05. Accordingly, 50 pregnant women were recruited in each group to compensate for potential dropouts.
Data were expressed as mean values ± standard deviation (SD) or number and percentage values. Whether the data has normal distribution was tested using Kolmogorov-Smirnov test. Comparisons were performed using the Mann-Whitney U-test, when data was not normally distributed. Comparisons were performed using the Independent T test in the presence of normally distributed data. The percentage values were compared using chi-square, P<0.05 was considered significant statistically.
- Conditions
- Obesity, Pregnancy Related, Cesarean Section Complications, Spinal Anaesthetic Poisoning of Undetermined Intent, Hypotension
- Being tested
- left lateral decubitus position, sitting position, The use of intravenous ephedrine., The use of intravenous atropine., The use of intravenous metoclopramide
- Keywords
- Combined spinal epidural anesthesia, obesity, cesarean section, lateral decubitus position, sitting position, hypotension
- Medical subject headings
- Obesity, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left lateral decubitus positionOther
Comparator group consisted of patients performing CSEA in the left lateral decubitus position.
sitting positionOther
Active control group consisted of patients performing CSEA in the sitting position.
The use of intravenous ephedrine.Drug
Intravenous ephedrine (6 mg) was used to treat hypotension (a 30% decrease in systolic blood pressure compared to preoperative values) during surgery.
The use of intravenous atropine.Drug
Intravenous atropine (1 mg) was given in case of bradycardia (the heart rate < 45 beats/minute) during surgery.
The use of intravenous metoclopramideDrug
When nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered.
| Study group | Role | What they receive |
|---|---|---|
| Comparator group | Sham comparator | Comparator group consisted of patients performing CSEA in the left lateral decubitus position. Receives: Other: left lateral decubitus position; Drug: The use of intravenous ephedrine.; Drug: The use of intravenous atropine.; Drug: The use of intravenous metoclopramide |
| Active control group | Active comparator | Active control group consisted of patients performing CSEA in the sitting position. Receives: Other: sitting position; Drug: The use of intravenous ephedrine.; Drug: The use of intravenous atropine.; Drug: The use of intravenous metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ephedrine requirement
The change in ephedrine requirement during surgery (mg).
Measured: Every two minutes during surgery.
Secondary outcomes (2)
atropine requirement
The change in atropine requirement during surgery (mg).
Measured: every two minutes during surgery
analgesic requirement
The change in analgesic requirement during surgery (mg).
Measured: every five minutes after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Feb 2017
- Primary completion1 Mar 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparator group consisted of patients performing CSEA in the left lateral decubitus position. Active control group consisted of patients performing CSEA in the sitting position.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet AKSOY, Ataturk University
- Investigators
- Mehmet AKSOY, Principal investigator, Faculty of Medicine, Ataturk University, Erzurum, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612998
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/11
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 3 Nov 2020
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Spinal Epidural Anesthesia in Obese Patients Undergoing Cesarean Surgery: A Randomised Comparison of Lateral Decubitus and Sitting Positions
- ClinicalTrials.gov ID
- NCT04612998
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/11
- Conditions
- Obesity, Pregnancy Related, Cesarean Section Complications, Spinal Anaesthetic Poisoning of Undetermined Intent, Hypotension
- Keywords
- Combined spinal epidural anesthesia, obesity, cesarean section, lateral decubitus position, sitting position, hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 3 Nov 2020 (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.
This study investigated the maternal and fetal effects during performance of CSEA in the left lateral decubitus and sitting positions in obese pregnant women undergoing elective cesarean section.
Detailed description
The study population comprised 100 pregnant women diagnosed with obese aged between 18-45 years, American society of anesthesiologist I and II with full-term gestation undergoing elective cesarean section under combined spinal - epidural anesthesia (CSEA). Women with psychiatric diseases, preeclampsia, pregnancy-induced hypertension or chronic hypertension, diabetes, multiple pregnancies, fetal anomaly and allergy to study drugs were excluded from the study. Also, patients requiring general anesthesia and patients with an average blood pressure below 90 and heart rate less than 50 were excluded. Before performance of CSEA, two groups were formed by randomization. A computer-generated table of random numbers was used for randomization. The CESA was performed in left lateral position in Group I (n=50) and in sitting position in Group II (n=50).
Premedication was not performed in any patient. Before entering the operating room, 10 mL/kg lactated Ringer's solution was given to all patients via IV cannula over 20 minutes. Standard monitoring was performed in the operating room. Before the operation; patients' age, weight, height, ASA physical status and basal hemodynamic parameters were recorded. The CSEA was planned for all patients. All interventions were performed by an experienced anesthesiologist. Patients were appropriately positioned in accordance with the group in which they were included. Group I (n=50) consisted of patients performing CSEA in the left lateral decubitus position. The patient was laid on her left side, the legs were flexed on the abdomen and the chin on the chest. Group II (n=50) consisted of patients performing CSEA in the sitting position. The patient was seated on the edge of the operating table with his feet hanging down, the feet supported by a chair, a pillow was given on her lap, and the patient clung to the pillow. After the skin was sterilized and local infiltration was performed with 2% lidocaine, 18 gauge Tuohy needle (Set for CSEA, Braun®, Melsungen, Germany) was advanced through the midline L2-3 or L3-4 intervertebral spaces with loss of resistance technique. Intrathecally, a 27-gauge pencil point needle was inserted using the needle-through-needle technique. When free cerebrospinal fluid flow was seen, 1.8 ml 0.5% isobaric bupivacaine (9 mg) was administered over 30 seconds. The epidural catheter was advanced 3 cm into the epidural space following the spinal needle was removed. After the catheter was checked with negative pressure, it was secured in place. At the end of the procedure patients were placed in the supine position for operation and the operating table was tilted 20° to the left. Sensory block level was evaluated via pinprick test and it was recorded bilaterally every two minutes. Surgery was initiated following the sensory block reached at the upper level of T6 dermatome. If signs of analgesia were not observed within the first 20 min following the spinal injection, spinal anesthesia was evaluated as failed. In case of failure, additional 5 ml solution of 2% lidocaine was performed via the epidural catheter (5-min intervals, the total dose of 15 mg) until a T6 level of the sensory block was provided. Motor block level was evaluated with Modified Bromage scale (scale 0 = motor block is not available; scale 1 = The patient can do the full flexion of foot and knee, she is unable to hip flexion; scale 2 = The patient can do the full flexion of foot, she is unable to knee and hip flexion; scale 3 = Total motor block is available). General anaesthesia protocol was applied in case of three unsuccessful attempts to reach to intrathecal space. Oxygen was delivered during surgery. Intravenous ephedrine (6 mg) was used to treat hypotension (a 30% decrease in systolic blood pressure compared to preoperative values) during surgery. Intra-venous atropine (1 mg) was given in case of bradycardia (the heart rate < 45 beats/minute) during surgery. When nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered. The application time of the CSEA, the time from the spinal injection to the development of sensory blockade up to T6 dermatome, operation time (the time from the start of the surgical incision until the end of surgery), highest sensory block level, anesthetic complications and the number of patients required epidural medication during surgery were recorded. Following drug administration to the intrathecal space, intraoperative hemodynamic changes were recorded every 2 min. After surgery was initiated, hemodynamic changes were recorded in 5-minute intervals until the end of the operation. Side effects such as pruritus and nausea, the number of patients requiring ephedrine, atropine or analgesic were recorded. After delivery, 30 IU oxytocin in 500 mL Ringer's lactate solution was given intravenously. Neonatal Apgar scores obtained at 1 and 5 min after delivery and umbilical artery blood gas values were recorded.
After surgery, patients were followed in the recovery room for 120 min. In the recovery room, Visual analogue scale (VAS, 0 cm= no pain, 10 cm= worst pain) scores for pain severity, anesthesia-related side effects (e.g., nausea, vomiting and headache), sensory block time (from the spinal injection to the recovery of T10 dermatome), and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively. In the case of VAS > 3 in a patient, 5 ml solution of 2% lidocaine was given through the epidural catheter. When the motor block had regressed to the T10 level, patients were sent to the clinics.Sample size was calculated as minimum 40 patients in each group, based on data obtained in previous studies, to detect a minimum difference in the requirement of 10 mg ephedrine between the two groups with a power of 90%, a of 0.05. Accordingly, 50 pregnant women were recruited in each group to compensate for potential dropouts.
Data were expressed as mean values ± standard deviation (SD) or number and percentage values. Whether the data has normal distribution was tested using Kolmogorov-Smirnov test. Comparisons were performed using the Mann-Whitney U-test, when data was not normally distributed. Comparisons were performed using the Independent T test in the presence of normally distributed data. The percentage values were compared using chi-square, P<0.05 was considered significant statistically.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparator group consisted of patients performing CSEA in the left lateral decubitus position. Active control group consisted of patients performing CSEA in the sitting position.
| Arm | Type | Receives |
|---|---|---|
| Comparator group | Sham comparator | Other: left lateral decubitus position, Drug: The use of intravenous ephedrine., Drug: The use of intravenous atropine., Drug: The use of intravenous metoclopramideComparator group consisted of patients performing CSEA in the left lateral decubitus position. |
| Active control group | Active comparator | Other: sitting position, Drug: The use of intravenous ephedrine., Drug: The use of intravenous atropine., Drug: The use of intravenous metoclopramideActive control group consisted of patients performing CSEA in the sitting position. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- obese women with full-term gestation
- aged between 18-45 years
- ASA (American society of anesthesiologist) I and II
- undergoing elective cesarean section with combined spinal-epidural anesthesia
Key exclusion criteria (8 listed)
- psychiatric diseases
- preeclampsia
- pregnancy-induced hypertension
- chronic hypertension
- diabetes
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 |
|---|---|---|
| left lateral decubitus positionComparator group consisted of patients performing CSEA in the left lateral decubitus position. | Other | Comparator group |
| sitting positionActive control group consisted of patients performing CSEA in the sitting position. | Other | Active control group |
| The use of intravenous ephedrine.Intravenous ephedrine (6 mg) was used to treat hypotension (a 30% decrease in systolic blood pressure compared to preoperative values) during surgery. | Drug | Active control group, Comparator group |
| The use of intravenous atropine.Intravenous atropine (1 mg) was given in case of bradycardia (the heart rate < 45 beats/minute) during surgery. | Drug | Active control group, Comparator group |
| The use of intravenous metoclopramideWhen nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered. | Drug | Active control group, Comparator group |
Primary outcome
ephedrine requirement
Time frame: Every two minutes during surgery.
The change in ephedrine requirement during surgery (mg).
2 secondary outcomes
atropine requirement
Time frame: every two minutes during surgery
analgesic requirement
Time frame: every five minutes after surgery.
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 3 Nov 2020.
- 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.
Mehmet AKSOY principal investigator
Faculty of Medicine, Ataturk University, Erzurum, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left lateral decubitus position, sitting position and The use of intravenous ephedrine. in people with Obesity and Pregnancy Related, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 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 3 Nov 2020. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
ephedrine requirement (time frame: Every two minutes during surgery.). 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 3 Nov 2020.