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Completed

NCT Number: NCT06345313

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.

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Key information

Conditions

Inflammatory Response

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, CANKAYA, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Day Group

Procedure

Patient group that will be operated on between 08.00-12.00

Night Group

Procedure

Patient group that will be operated on between 18.00-22.00

Primary outcomes

  1. Change of IL6 (interleukin6) (ng/ml)

    Time frame: 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 outcomes

  1. Quality of recovery from anesthesia according to difference in circadian rhythm

    Time frame: 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.

  2. Change of NLR ( Neutrophil/ Lymphocyte Ratio )

    Time frame: 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.

  3. Change of PLR ( Platelet / Lymphocyte Ratio )

    Time frame: 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.

  4. Change of SII (Systemic immune-inflammation index )

    Time frame: 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.

  5. Change of CRP (C Reactive Protein) (mg/dl)

    Time frame: 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.

  6. Change of Fibrinogen (mg)

    Time frame: 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.

  7. Change of Sedimentation (mm/hour)

    Time frame: 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.

  8. Change of Procalcitonin (µg/l)

    Time frame: 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.

  9. Change of Ferritin (ml/ng)

    Time frame: 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.

Other outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: Postoperative 24th hour

    NRS is a scale that uses 11 numbers (between 0 and 10) to measure pain intensity. 0: no pain 10: unbearable pain

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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