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

A

Ankara City Hospital

Status

Completed

Conditions

Inflammatory Response

Treatments

Procedure: Day Group
Procedure: Night Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06345313
Inflammation (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Day Group
Active Comparator group
Description:
Participants who underwent inguinal herniography operation between 08.00-12.00
Treatment:
Procedure: Day Group
Night Group
Active Comparator group
Description:
Participants who underwent inguinal herniography operation between 18.00-22.00
Treatment:
Procedure: Night Group

Trial contacts and locations

1

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Central trial contact

Burcu Dikmen Demiryorgan

Data sourced from clinicaltrials.gov

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