Sex Difference Effects on Postoperative Sleep, Inflammation and Cognition in Patients Undergoing General Anesthesia

NCT05059548 | Unknown

• 1 other identifier: Sex, cognition, inflammation
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation, sleep quality and cognitive function among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.

Conditions

Sex Differences; Postoperative Sleep Quality; Postoperative Pain; Inflammation Function; Postoperative Cognitive Function

Outcome Measures

Primary Outcomes (12)

• sleep quality of one night before surgery

  use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)

  one night before surgery

• sleep quality of first night after surgery

  use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)

  first night after surgery

• sleep quality of third night after surgery

  use the athens insomnia scale to evaluate subjective sleep quality (0 to 24 points, with ≥ 6 points indicating a diagnosis of insomnia)

  third night after surgery

• preoperative inflammation function

  evaluate systemic immune inflammation index (SII) before operation

  three days before surgery

• preoperative inflammation function

  evaluate neutrophil / lymphocyte ratio (NLR)before operation

  three days before surgery

• preoperative inflammation function

  evaluate platelet / lymphocyte ratio (PLR) before operation

  three days before surgery

• preoperative inflammation function

  evaluate monocyte / lymphocyte ratio (MLR) before operation

  three days before surgery

• postoperative inflammation function

  evaluate systemic immune inflammation index (SII) after operation

  three days after surgery

• postoperative inflammation function

  evaluate neutrophil / lymphocyte ratio (NLR) after operation

  three days after surgery

• postoperative inflammation function

  evaluate platelet / lymphocyte ratio (PLR) after operation

  three days after surgery

• postoperative inflammation function

  evaluate monocyte / lymphocyte ratio (MLR) after operation

  three days after surgery

• neuropsychological test

  The neuropsychological test battery included the tests used to evaluate patients for delayed neurocognitive recovery in the International Study of Post-Operative Cognitive Dysfunction: (1) word learning: visual verbal learning test based on the Rey's auditory recall of words; (2) word recall: the number or words recalled from visual verbal learning trials after a 20-min delay; (3) cognitive flexibility: including trail making test A and B; (4) distractibility: Stroop color word interference test; and (5) working memory: letter-digit coding. If a patient exhibited delirium at a testing time, neuropsychological evaluation was postponed 3 days.

  Neuropsychological tests were carried out the day before and 5 to 7 days after surgery. The second neuropsychological test time for control subjects was 6 to 9 d

Secondary Outcomes (2)

• visual analog scale(VAS) score after surgery

  24 hours after surgery

• postoperative adverse effects

  24 hours after surgery

Study Arms (2)

Male Group

Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Other: Video-Assisted Thoracoscopic Surgery

Female Group

Video-Assisted Thoracoscopic Surgery patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Other: Video-Assisted Thoracoscopic Surgery

Interventions

Video-Assisted Thoracoscopic Surgery OTHER

patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia

Female Group; Male Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing video-assisted thoracoscopic surgery under general anesthesia

You may qualify if:

• years old
• ASA I-III
• under general anesthesia

You may not qualify if:

• patients with central nervous system and mental diseases;
• patients with preoperative sleep disturbances;
• patients with a history of sedative, analgesic, or antidepression drug use;
• patients with sleep apnea or moderate and severe obstructive sleep apneahypopnea syndrome;

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• junchao zhu

  Shengjing Hospital

  STUDY DIRECTOR

Central Study Contacts

junchao zhu

CONTACT

+8618940257257; zhujunchao1@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 28, 2021
• Study Start: September 20, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

CN (1)