EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES

Inflammatory Response Clinical Trial

Official title:

EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345313
• Other study ID #: CIRCADIAN RHYTHM
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: March 2024
• Source: Ankara City Hospital Bilkent
• Contact: Burcu Dikmen Demiryorgan
• Phone: +905067611029
• Email: burcudikmen325[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

Other:
• Day Group
Patient group that will be operated on between 08.00-12.00
• Night Group
Patient group that will be operated on between 18.00-22.00

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative pain scores according to the difference in circadian rhythm	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
Primary	Change of IL6 (interleukin) (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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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