Smoking CigaretteNCT05343845
Does Smoking Effect Spinal Anesthesia?
An observational study of Smoking Cigarette and Spinal Anaesthesia, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Background In the last 10 years, the rate of smoking in women of childbearing age has increased gradually. The smoking affects general anesthesia negatively. Can smoking also affect regional anesthesia in pregnant women? Our aim in this study is to investigate the effects of smoking on spinal anesthesia applied for… 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
- Smoking Cigarette, Spinal Anaesthesia, Pregnancy
- What is being tested?
- Observational study
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 30 Jul 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: The data of 100 parturients will be investigated.
Who may be able to join
- Patients with an American Society of Anesthesiologists (ASA) status of class I-II,
- Aged between 18 and 45 years,
- Scheduled to undergo spinal anesthesia for elective C/S
Who cannot join
- The requirement of emergency C/S for delivery,
- ASA class ≥ III patients,
- A contraindication for spinal anesthesia,
- Multiple gestations,
- Placental abnormalities
- Allergy to local anesthetics,
Show all 9Show fewer
- Height shorter than 150 cm,
- Coagulation disorders and
- Refusal of spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Yüzüncü Yıl University, Faculty of Medicine
Van, Tusba, 65080
Hacı Yusuf YG Guneş, Asist prof, +904322150473 ext. 6080, hyusufgunes@hotmail.com
Nureddin NY Yuzkat, Assoc prof, +904322150473 ext. 6080, nyuzkat@gmail.com
About this study
Official title: Does Smoking Effect Spinal Anesthesia in Parturient Women? A Randomized-controlled Trial
Background In the last 10 years, the rate of smoking in women of childbearing age has increased gradually. The smoking affects general anesthesia negatively. Can smoking also affect regional anesthesia in pregnant women? Our aim in this study is to investigate the effects of smoking on spinal anesthesia applied for C/S in pregnant women.
Methods After approval of the institution's ethics committee, 100 patients will divided in two groups as pregnant women who did not smoke during pregnancy and pregnant women who smoked 5 or more cigarettes in a day. The local anesthetic, which dose will be adjusted according to height and weight, and 20 µg fentanyl will administered intrathecally to both groups. Results on the effectiveness of spinal anesthesia will monitored.
Read more
Results The data of 100 parturients will investigated. The onset time of sensory and motor block, the duration of motor and sensory block, APGAR and VAS scores will be monitored. In addition, C/S indications, side effects, patient satisfaction, additional medication need and, spinal anesthesia preferences will be monitored.
Conclusions Smoking affects many systems. According to the onset of sensory block, duration of sensory and motor block and, VAS scores, which determine the effectiveness of spinal anesthesia, it will be evaluated whether smoking also affects spinal anesthesia in pregnant women.
Read the detailed description
MATERIALS AND METHODS
Ethical approval:
This prospective, randomized-controlled, observational study was conducted at Van Research and Training Hospital with a bed capacity of 1500 located in Van, Turkey. Approval was obtained from the institution's ethics committee (2019/18), and the study was performed according to the World Medical Association's Declaration of Helsinki. All enrolled patients provided written informed consent.
Groups and Randomization: The patients included in the study will be divided into two groups. Pregnant women who did not smoke during pregnancy (Group NS, Non-Smoker) (n=50) and pregnant women who smoked 5 or more cigarettes per day (Group S, Smoker) (n=50) will be randomly included in the study.
Procedure: 8-10 mL/kg of crystalloid fluid intravenous hydration will be administered for 10-15 minutes to each patient taken to the operating table. Electrocardiography (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) monitoring will be routinely performed. NIBP values, heart rate (HR), and SpO2 values will be recorded before the procedure (T0).
After proper skin cleansing and sterile preparation with povidone-iodine, spinal anesthesia will be performed in a sitting position with a 25 gauge Quincke spinal needle at L3-4/4-5 level. After free cerebrospinal fluid (CSF) flow is seen, 7.5-10 mg heavy 0.5% (Marcaine spinal heavy, AstraZeneca PLC, Istanbul, Turkey) and 20 µg fentanyl (fentanyl 0.05 mg/ml, Johnson and Johnson, Istanbul, Turkey) ) will be administered intrathecally. Local anesthetic dose will be adjusted according to height and weight. Until the beginning of the surgical procedure, patients will be placed in a supine position with their heads slightly elevated and the operating table facing 15-20 degrees to the left to minimize aortocaval compression. The sensory block levels of the patients will be evaluated with the cold-hot test, and the motor block levels will be evaluated with the Bromage Scale at 2-minute intervals for the first 10 minutes. After intrathecal drug administration, the 1st (T1), 2nd (T2), 3rd (T3), 4th (T4), 5th (T5), 10th (T6), 15th (T7), 20th, and thirtieth Within minutes, hemodynamic parameters and SpO2 values will be recorded.
The onset time of sensory block: Time taken for the sensory block to reach the T6 dermatome.
The onset time of motor block: Time taken for the motor block to reach a Bromage score of 3.
After the adequate level of sensory block was achieved (thoracic 4-6 dermatome levels), the surgical procedure would be started. All patients will be given oxygen at a rate of 3 L/min with a face mask.
Duration of motor block: The overall duration of motor block was defined as the start of the motor block to the time when the motor block regressed to the level of 0 according to the Bromage Scale.
Duration of sensory block: The overall duration of sensory block was defined as the start of the sensory block to the time when the sensory block regressed to the level of the L1 dermatome. Sensory and motor block levels will be checked every 15 minutes intraoperatively and postoperatively, and sensory and motor block times will be recorded.
The time between the surgical incision and the clamping of the umbilical cord will be recorded. After the delivery of the newborn and the removal of the placenta, 20 IU of synthetic oxytocin will be infused in 1000 mL of crystalloid fluid. If needed, one ampoule of methylergonovine will administered intramuscularly (im). The patients who had discomfort during peritoneal irritation will sedated with fentanyl (50 mcg) and/or propofol, and the medications that were used will be recorded. Metoclopramide (10 mg) and ranitidine (50 mg) will administered intravenous to the patients with complaints of nausea and vomiting.
A decrease in MAP by more than 20% from the baseline or a decrease in MAP below 65 mmHg in the intraoperative period will considered as hypotension, and iv bolus of ephedrine (10 mg) will administered. The amount of ephedrine used during the operation will be recorded. When the heart rate fell below 50 beats/min, it will considered as bradycardia, and 0.5-0.75 mg of iv atropine will administered. A decrease in SpO2 below 90% will considered as low peripheral oxygen saturation, and the amount of oxygen given to these patients by a facemask will increased to 4-5 L/min.
Side effects such as nausea, vomiting, headache, chest pain, hypotension, and bradycardia will be recorded. The 1st- and 5th-minute APGAR scores of the newborns will be recorded. The satisfaction level of the patients (scored as not satisfied, less satisfied, very satisfied) will be recorded. The time between the beginning of the surgical incision and the last suture to close the skin will be recorded as the operation duration. The patients will be informed about the Visual Analogue Scale, which would be used to evaluate the pain they felt preoperatively, intraoperatively and postoperatively (0: No pain - 10: extreme pain). In the postoperative period, if the VAS score will 4 or higher, 1000 mg paracetamol will be administered intravenously for analgesia.
Statistical analysis: The statistical analyses will be performed using the Statistical Package for the Social Sciences 27.0 software for Windows (SPSS, Chicago, IL, USA).
Descriptive statistics will be presented as mean, standard deviation, median, minimum, maximum, frequency and percentage values. The distributions of the variables will evaluated with Kolmogorov-Smirnov test. Independent-samples t-test and Mann-Whitney U test will be used in the analyses of the quantitative data in independent groups. Chi-squared test will be used in the analyses of the qualitative data in independent groups, and Fisher's test will be used when the chi-squared test conditions were not met.
- Conditions
- Smoking Cigarette, Spinal Anaesthesia, Pregnancy, Cesarean Section
- Being tested
- Observational study
- Keywords
- Spinal anesthesia, Cesarean section, Pregnant women, Smoking
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
After approval of the institution's ethics committee, 100 patients will be divided in two groups as pregnant women who did not smoke during pregnancy and pregnant women who smoked 5 or more cigarettes in a day. The local anesthetic, which dose will adjusted according to height and weight, and 20 µg fentanyl will be administered intrathecally to both groups. Results on the effectiveness of spinal anesthesia will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Group NS, Nonsmoker (n= 50) | Pregnant women who did not smoke during pregnancy will be separated as Group NS. Local anesthetic dose adjusted for height and weight and 20 µg fentanyl will be administered intrathecally. Results regarding the effectiveness of spinal anesthesia will be monitored. Receives: Other: Observational study | |
| Group S, Smoker (n= 50) | Pregnant women who smoked 5 or more cigarettes in a day will be separated as Group S. A local anesthetic dose adjusted for height and weight and 20 µg fentanyl will be administered intrathecally. Results regarding the effectiveness of spinal anesthesia will be monitored. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block onset,
After intrathecal drug administration, sensory block levels will be checked with cold-hot test per one-minute intervals in the first 10 minutes. Time taken for sensory block to reach T6 dermatome will be recorded.
Measured: The sensory block onset will assessed 3 min after administering the spinal anesthetic, up to 10 minute.
Duration of motor block,
Motor block levels will be checked with the Bromage Scale every minute for the first 10 minutes after intrathecal drug administration.
Overall duration of motor block was defined as the start of the motor block to the time when the motor block regresses to 0 level according to the Bromage scale.The motor block test will be repeated every 15 minutes during and after surgery until the Bromage Scale regresses to 0 point.
Measured: The motor block will be followed until Bromage scales regress to zero point, up to 6 hour.
Duration of sensory block,
After intrathecal drug administration, sensory block levels will be checked with cold-hot tes at 2-minute intervals in the first 10 minutes. The cold-hot test will be repeated every 15 minutes during and after surgery until the the sensory block regressed to the level of the L1 dermatome. Overall duration of sensory block was defined as the start of the sensory block to the time when the sensory block regresses to L-1 dermatome level.
Measured: The duration of sensory block will be controlled until it regresses to the L1 level, up to 6 hour.
VAS scores
Patients will be informed about the Visual Analogue Scale, which will be used to evaluate the pain they felt preoperatively, intraoperatively and postoperatively (0; No pain - 10; extreme pain).
Measured: Pain level will be checked with VAS score at 4-hour intervals up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start28 Feb 2022
- Primary completion15 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CigaretteStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacı Yusuf Güneş, Yuzuncu Yil University
- Investigators
- Hacı Yusuf YG Güneş, Assist.prof, Principal investigator, Van Yüzüncü Yıl University, Van Research and Training Hospital, Van, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343845
- Sponsor's protocol ID
- 2019/18
- Status last verified
- Apr 2022
- First submitted
- 28 Feb 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan will be share for other researchers
Publications
Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.
PubMed 31380506Dias-Dame JL, Cesar JA. Disparities in prevalence of smoking and smoking cessation during pregnancy: a population-based study. Biomed Res Int. 2015;2015:345430. doi: 10.1155/2015/345430. Epub 2015 May 14.
PubMed 26075231Al-Noori NM, Ibraheem NS, Abdulmunem MM. The impact of cigarette smoking on the efficiency of local anesthesia during simple tooth extraction. Saudi Dent J. 2021 Nov;33(7):674-678. doi: 10.1016/j.sdentj.2020.04.011. Epub 2020 May 7.
PubMed 34803318
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Smoking Effect Spinal Anesthesia in Parturient Women? A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05343845
- Acronym / sponsor ID
- 2019/18
- Conditions
- Smoking Cigarette, Spinal Anaesthesia, Pregnancy, Cesarean Section
- Keywords
- Spinal anesthesia, Cesarean section, Pregnant women, Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 25 Apr 2022 (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.
Background In the last 10 years, the rate of smoking in women of childbearing age has increased gradually. The smoking affects general anesthesia negatively. Can smoking also affect regional anesthesia in pregnant women? Our aim in this study is to investigate the effects of smoking on spinal anesthesia applied for C/S in pregnant women.
Methods After approval of the institution's ethics committee, 100 patients will divided in two groups as pregnant women who did not smoke during pregnancy and pregnant women who smoked 5 or more cigarettes in a day. The local anesthetic, which dose will be adjusted according to height and weight, and 20 µg fentanyl will administered intrathecally to both groups. Results on the effectiveness of spinal anesthesia will monitored.
Results The data of 100 parturients will investigated. The onset time of sensory and motor block, the duration of motor and sensory block, APGAR and VAS scores will be monitored. In addition, C/S indications, side effects, patient satisfaction, additional medication need and, spinal anesthesia preferences will be monitored.
Conclusions Smoking affects many systems. According to the onset of sensory block, duration of sensory and motor block and, VAS scores, which determine the effectiveness of spinal anesthesia, it will be evaluated whether smoking also affects spinal anesthesia in pregnant women.
Detailed description
MATERIALS AND METHODS
Ethical approval:
This prospective, randomized-controlled, observational study was conducted at Van Research and Training Hospital with a bed capacity of 1500 located in Van, Turkey. Approval was obtained from the institution's ethics committee (2019/18), and the study was performed according to the World Medical Association's Declaration of Helsinki. All enrolled patients provided written informed consent.
Groups and Randomization: The patients included in the study will be divided into two groups. Pregnant women who did not smoke during pregnancy (Group NS, Non-Smoker) (n=50) and pregnant women who smoked 5 or more cigarettes per day (Group S, Smoker) (n=50) will be randomly included in the study.
Procedure: 8-10 mL/kg of crystalloid fluid intravenous hydration will be administered for 10-15 minutes to each patient taken to the operating table. Electrocardiography (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) monitoring will be routinely performed. NIBP values, heart rate (HR), and SpO2 values will be recorded before the procedure (T0).
After proper skin cleansing and sterile preparation with povidone-iodine, spinal anesthesia will be performed in a sitting position with a 25 gauge Quincke spinal needle at L3-4/4-5 level. After free cerebrospinal fluid (CSF) flow is seen, 7.5-10 mg heavy 0.5% (Marcaine spinal heavy, AstraZeneca PLC, Istanbul, Turkey) and 20 µg fentanyl (fentanyl 0.05 mg/ml, Johnson and Johnson, Istanbul, Turkey) ) will be administered intrathecally. Local anesthetic dose will be adjusted according to height and weight. Until the beginning of the surgical procedure, patients will be placed in a supine position with their heads slightly elevated and the operating table facing 15-20 degrees to the left to minimize aortocaval compression. The sensory block levels of the patients will be evaluated with the cold-hot test, and the motor block levels will be evaluated with the Bromage Scale at 2-minute intervals for the first 10 minutes. After intrathecal drug administration, the 1st (T1), 2nd (T2), 3rd (T3), 4th (T4), 5th (T5), 10th (T6), 15th (T7), 20th, and thirtieth Within minutes, hemodynamic parameters and SpO2 values will be recorded.
The onset time of sensory block: Time taken for the sensory block to reach the T6 dermatome.
The onset time of motor block: Time taken for the motor block to reach a Bromage score of 3.
After the adequate level of sensory block was achieved (thoracic 4-6 dermatome levels), the surgical procedure would be started. All patients will be given oxygen at a rate of 3 L/min with a face mask.
Duration of motor block: The overall duration of motor block was defined as the start of the motor block to the time when the motor block regressed to the level of 0 according to the Bromage Scale.
Duration of sensory block: The overall duration of sensory block was defined as the start of the sensory block to the time when the sensory block regressed to the level of the L1 dermatome. Sensory and motor block levels will be checked every 15 minutes intraoperatively and postoperatively, and sensory and motor block times will be recorded.
The time between the surgical incision and the clamping of the umbilical cord will be recorded. After the delivery of the newborn and the removal of the placenta, 20 IU of synthetic oxytocin will be infused in 1000 mL of crystalloid fluid. If needed, one ampoule of methylergonovine will administered intramuscularly (im). The patients who had discomfort during peritoneal irritation will sedated with fentanyl (50 mcg) and/or propofol, and the medications that were used will be recorded. Metoclopramide (10 mg) and ranitidine (50 mg) will administered intravenous to the patients with complaints of nausea and vomiting.
A decrease in MAP by more than 20% from the baseline or a decrease in MAP below 65 mmHg in the intraoperative period will considered as hypotension, and iv bolus of ephedrine (10 mg) will administered. The amount of ephedrine used during the operation will be recorded. When the heart rate fell below 50 beats/min, it will considered as bradycardia, and 0.5-0.75 mg of iv atropine will administered. A decrease in SpO2 below 90% will considered as low peripheral oxygen saturation, and the amount of oxygen given to these patients by a facemask will increased to 4-5 L/min.
Side effects such as nausea, vomiting, headache, chest pain, hypotension, and bradycardia will be recorded. The 1st- and 5th-minute APGAR scores of the newborns will be recorded. The satisfaction level of the patients (scored as not satisfied, less satisfied, very satisfied) will be recorded. The time between the beginning of the surgical incision and the last suture to close the skin will be recorded as the operation duration. The patients will be informed about the Visual Analogue Scale, which would be used to evaluate the pain they felt preoperatively, intraoperatively and postoperatively (0: No pain - 10: extreme pain). In the postoperative period, if the VAS score will 4 or higher, 1000 mg paracetamol will be administered intravenously for analgesia.
Statistical analysis: The statistical analyses will be performed using the Statistical Package for the Social Sciences 27.0 software for Windows (SPSS, Chicago, IL, USA).
Descriptive statistics will be presented as mean, standard deviation, median, minimum, maximum, frequency and percentage values. The distributions of the variables will evaluated with Kolmogorov-Smirnov test. Independent-samples t-test and Mann-Whitney U test will be used in the analyses of the quantitative data in independent groups. Chi-squared test will be used in the analyses of the qualitative data in independent groups, and Fisher's test will be used when the chi-squared test conditions were not met.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group NS, Nonsmoker (n= 50) | – | Other: Observational studyPregnant women who did not smoke during pregnancy will be separated as Group NS. Local anesthetic dose adjusted for height and weight and 20 µg fentanyl will be administered intrathecally. Results regarding the effectiveness of spinal anesthesia will be monitored. |
| Group S, Smoker (n= 50) | – | Other: Observational studyPregnant women who smoked 5 or more cigarettes in a day will be separated as Group S. A local anesthetic dose adjusted for height and weight and 20 µg fentanyl will be administered intrathecally. Results regarding the effectiveness of spinal anesthesia will be monitored. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The data of 100 parturients will be investigated.
Key inclusion criteria (3 listed)
- Patients with an American Society of Anesthesiologists (ASA) status of class I-II,
- Aged between 18 and 45 years,
- Scheduled to undergo spinal anesthesia for elective C/S
Key exclusion criteria (9 listed)
- The requirement of emergency C/S for delivery,
- ASA class ≥ III patients,
- A contraindication for spinal anesthesia,
- Multiple gestations,
- Placental abnormalities
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 |
|---|---|---|
| Observational studyAfter approval of the institution's ethics committee, 100 patients will be divided in two groups as pregnant women who did not smoke during pregnancy and pregnant women who smoked 5 or more cigarettes in a day. The local anesthetic, which dose will adjusted according to height and weight, and 20 µg fentanyl will be administered intrathecally to both groups. Results on the effectiveness of spinal anesthesia will be monitored. | Other | Group NS, Nonsmoker (n= 50), Group S, Smoker (n= 50) |
Primary outcome
Sensory block onset,
Time frame: The sensory block onset will assessed 3 min after administering the spinal anesthetic, up to 10 minute.
After intrathecal drug administration, sensory block levels will be checked with cold-hot test per one-minute intervals in the first 10 minutes. Time taken for sensory block to reach T6 dermatome will be recorded.
Duration of motor block,
Time frame: The motor block will be followed until Bromage scales regress to zero point, up to 6 hour.
Motor block levels will be checked with the Bromage Scale every minute for the first 10 minutes after intrathecal drug administration. Overall duration of motor block was defined as the start of the motor block to the time when the motor block regresses to 0 level according to the Bromage scale.The motor block test will be repeated every 15 minutes during and after surgery until the Bromage Scale regresses to 0 point.
Duration of sensory block,
Time frame: The duration of sensory block will be controlled until it regresses to the L1 level, up to 6 hour.
After intrathecal drug administration, sensory block levels will be checked with cold-hot tes at 2-minute intervals in the first 10 minutes. The cold-hot test will be repeated every 15 minutes during and after surgery until the the sensory block regressed to the level of the L1 dermatome. Overall duration of sensory block was defined as the start of the sensory block to the time when the sensory block regresses to L-1 dermatome level.
VAS scores
Time frame: Pain level will be checked with VAS score at 4-hour intervals up to 24 hours.
Patients will be informed about the Visual Analogue Scale, which will be used to evaluate the pain they felt preoperatively, intraoperatively and postoperatively (0; No pain - 10; extreme pain).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 31380506Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.
- Background: PubMed 26075231Dias-Dame JL, Cesar JA. Disparities in prevalence of smoking and smoking cessation during pregnancy: a population-based study. Biomed Res Int. 2015;2015:345430. doi: 10.1155/2015/345430. Epub 2015 May 14.
- Background: PubMed 34803318Al-Noori NM, Ibraheem NS, Abdulmunem MM. The impact of cigarette smoking on the efficiency of local anesthesia during simple tooth extraction. Saudi Dent J. 2021 Nov;33(7):674-678. doi: 10.1016/j.sdentj.2020.04.011. Epub 2020 May 7.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan will be share for other researchers
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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.
Hacı Yusuf YG Güneş, Assist.prof principal investigator
Van Yüzüncü Yıl University, Van Research and Training Hospital, Van, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cigarette and Spinal Anaesthesia, run by Yuzuncu Yil 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 3 inclusion and 9 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 25 Apr 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacı Yusuf YG Güneş, Assist.prof (+904322150473 ext. 6080, hyusufgunes@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory block onset, (time frame: The sensory block onset will assessed 3 min after administering the spinal anesthetic, up to 10 minute.). The study lists 4 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 NCT05343845, which also lists 3 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 25 Apr 2022.