Clinical trial NCT06345313: The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery
Official title: The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Keywords: CIRCADIAN RHYTHM
POSTOPERATİVE RECOVERY
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of IL6 (interleukin6) (ng/ml)
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Quality of recovery from anesthesia according to difference in circadian rhythm
timeFrame: Postoperative 24th hour
measure: Change of NLR ( Neutrophil/ Lymphocyte Ratio )
timeFrame: Postoperative 24th hour
measure: Change of PLR ( Platelet / Lymphocyte Ratio )
timeFrame: Postoperative 24th hour
measure: Change of SII (Systemic immune-inflammation index )
timeFrame: Postoperative 24th hour
measure: Change of CRP (C Reactive Protein) (mg/dl)
timeFrame: Postoperative 24th hour
measure: Change of Fibrinogen (mg)
timeFrame: Postoperative 24th hour
measure: Change of Sedimentation (mm/hour)
timeFrame: Postoperative 24th hour
measure: Change of Procalcitonin (µg/l)
timeFrame: Postoperative 24th hour
measure: Change of Ferritin (ml/ng)
timeFrame: Postoperative 24th hour
Other outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Postoperative 24th hour
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Cankaya
Study officials:
References: