Does Smoking Effect Spinal Anesthesia?

NCT05343845 | Unknown

• 1 other identifier: 2019/18
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Smoking Cigarette; Spinal Anaesthesia; Pregnancy; Cesarean Section

Keywords

Spinal anesthesia; Cesarean section; Pregnant women; Smoking

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  Pain level will be checked with VAS score at 4-hour intervals up to 24 hours.

Study Arms (2)

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.

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.

Other: Observational study

Interventions

Observational study OTHER

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.

Group NS, Nonsmoker (n= 50); Group S, Smoker (n= 50)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Aged between 18 and 45 years, scheduled to undergo spinal anesthesia for elective C/S will be included in this study. Pregnancy is a woman-specific condition.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The data of 100 parturients will be investigated.

You may qualify if:

• 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

You may not qualify if:

• 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,
• Height shorter than 150 cm,
• Coagulation disorders and
• Refusal of spinal anesthesia.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University, Faculty of Medicine

Van, Tusba, 65080, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 31380506 BACKGROUND

• Dias-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.

  PMID: 26075231 BACKGROUND

• Al-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.

  PMID: 34803318 BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Interventions

Observation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Hacı Yusuf YG Güneş, Assist.prof

  Van Yüzüncü Yıl University, Van Research and Training Hospital, Van, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hacı Yusuf YG Güneş, Assist.prof

CONTACT

+904322150473; hyusufgunes@hotmail.com

Nureddin NY Yüzkat, Assoc prof

CONTACT

+904322150473; nyuzkat@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant proffesor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 25, 2022
• Study Start: February 28, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year
• Access Criteria: The access can be provided via the e-mail addresses below. hyusufgunes@hotmail.com nyuzkat@gmail.com

Locations

TU (1)