The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Response
• Intervention / Treatment: Procedure: Day Group; Procedure: Night Group

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Day Group; Participants who underwent inguinal herniography operation between 08.00-12.00	Procedure: Day Group; Patient group that will be operated on between 08.00-12.00
Active Comparator: Night Group; Participants who underwent inguinal herniography operation between 18.00-22.00	Procedure: Night Group; Patient group that will be operated on between 18.00-22.00

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IL6 (interleukin6) (ng/ml)	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.	Postoperative 24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery from anesthesia according to difference in circadian rhythm	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.	Postoperative 24th hour
Change of NLR ( Neutrophil/ Lymphocyte Ratio )	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.	Postoperative 24th hour
Change of PLR ( Platelet / Lymphocyte Ratio )	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.	Postoperative 24th hour
Change of SII (Systemic immune-inflammation index )	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.	Postoperative 24th hour
Change of CRP (C Reactive Protein) (mg/dl)	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.	Postoperative 24th hour
Change of Fibrinogen (mg)	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.	Postoperative 24th hour
Change of Sedimentation (mm/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.	Postoperative 24th hour
Change of Procalcitonin (µg/l)	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.	Postoperative 24th hour
Change of Ferritin (ml/ng)	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.	Postoperative 24th hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS)	NRS is a scale that uses 11 numbers (between 0 and 10) to measure pain intensity. 0: no pain 10: unbearable pain	Postoperative 24th hour

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: CIRCADIAN RHYTHM; POSTOPERATİVE RECOVERY
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Inflammation (Amgen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No