EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES
- Conditions
- Inflammatory Response
- Interventions
- Procedure: Day GroupProcedure: Night Group
- Registration Number
- NCT06345313
- Lead Sponsor
- Ankara City Hospital Bilkent
- Brief Summary
To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour.
- Detailed Description
Participants who would undergo unilateral inguinal herniography surgery at different times during the day were determined into two groups: day (08.00-12.00) and night (18.00-22.00). The Athens Insomnia Scale (AIS) will be asked verbally on the first preoperative day to determine the participants' preoperative circadian rhythm adaptation and sleep status. Serum inflammatory parameters of both participant groups will be measured and recorded at the preoperative 1st hour and the postoperative 24th hour. A laryngeal mask will be applied to the participants after induction with 2-3 mg/kg propofol and 1mg/kg fentanyl, as in routine anesthesia practice. Anesthesia maintenance will be provided with sevoflurane and 0.05-0.2 mcg/kg/min remifentanil infusion. Participants' age, gender, weight, height, BMI (body mass index), comorbidities, medications used, surgeries, ASA (American society of anesthesiologists) scoring, preoperative AIS (Athens insomnia scale) score, and preoperative laboratory data will be recorded. At the same time, participants' postoperative hospital stay, resting and moving NRS (Numeric rating scale) scores at the 24th postoperative hour, and recovery quality (Qor-15 score) from anesthesia will be recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA (American society of anesthesiologists) 1-2 adult participants between the ages of 18-70 who will undergo unilateral inguinal herniorrhaphy surgery at the Republic of Turkey Ministry of Health Ankara City Hospital.
- Do not want to participate in the study
- Younger than 18 or older than 70
- Scores 6 and above on the preoperative Athens Insomnia Scale.
- ASA (American society of anesthesiologists) scores of 3 or greater than 3
- Have contraindications to the use of anesthetic drugs
- BMI>30 kg/m^2
- Have bilateral herniorrhaphy surgery
- Complicated inguinal hernia (incarcerated, strangulated...)
- Pregnancy
- Emergency surgeries
- Laparoscopic surgeries
- Develop an unexpected intraoperative surgical complication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Day Group Day Group Participants who underwent inguinal herniography operation between 08.00-12.00 Night Group Night Group Participants who underwent inguinal herniography operation between 18.00-22.00
- Primary Outcome Measures
Name Time Method Change of IL6 (interleukin6) (ng/ml) Postoperative 24th hour IL6 (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation and trauma that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
- Secondary Outcome Measures
Name Time Method Change of NLR ( Neutrophil/ Lymphocyte Ratio ) Postoperative 24th hour NLR (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Change of CRP (C Reactive Protein) (mg/dl) Postoperative 24th hour CRP (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Change of Fibrinogen (mg) Postoperative 24th hour Fibrinogen (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Change of Procalcitonin (µg/l) Postoperative 24th hour Procalcitonin (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Quality of recovery from anesthesia according to difference in circadian rhythm Postoperative 24th hour The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. Higher results mean better build quality.
Change of SII (Systemic immune-inflammation index ) Postoperative 24th hour SII (Neutrophil × Platelet/ Lymphocyte) (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Change of Ferritin (ml/ng) Postoperative 24th hour Ferritin (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Change of PLR ( Platelet / Lymphocyte Ratio ) Postoperative 24th hour PLR (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Change of Sedimentation (mm/hour) Postoperative 24th hour Sedimentation (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Trial Locations
- Locations (1)
Ankara Bilkent City Hospital
🇹🇷Ankara, Cankaya, Turkey