Effect of General and Non-general Anesthesia on Perioperative Depression or Anxiety

NCT05315648 | Completed

• 1 other identifier: SAHoWMU-CR2021-03-109
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative depression and/or anxiety play a critical role in patient presentation, satisfaction and outcomes. The aim of this study is to assess the level of perioperative depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their relationship with anesthesia approach (general anesthesia or non general anesthesia). The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires and the level of salivary cortisol, salivary α-amylase (sAA) and blood glucose.

Conditions

Depression, Anxiety

Keywords

perioperative anxiety or depression; general anesthesia; salivary cortisol; salivary α-amylase; Hospital Anxiety and Depression Scale; stress response; non-general anesthesia

Outcome Measures

Primary Outcomes (5)

• The rate of Anxiety symptoms (HADS-A)

  The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression. The score for each individual item could vary from 0 to 3, so that the total score for each scale about anxiety (HADS-A) ranges from 0 to 21. If the score was 0-7, indicating that there was no anxiety; the score was 8-10, suspected anxiety; 11-14, moderate anxiety; the score was 15-21, severe anxiety. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.

  one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital

• The rate of Depression symptoms (HADS-D)

  The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression. The score for each individual item could vary from 0 to 3, so that the total score for each scale about depression (HADS-D) ranges from 0 to 21. If the score was 0-7, indicating that there was no depression; the score was 8-10, suspected depression; 11-14, moderate depression; the score was 15-21, severe depression. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.

  one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital

• The changes of salivary cortisol concentration

  Enzyme immunoassay for the quantitative determination of free Cortisol in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.

  on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)

• The changes of Saliva α- amylase activity

  Enzymatic assay for the determination of alpha amylase activity in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.

  on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)

• The changes of Blood glucose level

  Using a glucose meter to check and monitor blood sugar via finger stick

  on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)

Secondary Outcomes (9)

• The changes of swelling rating

  at 6, 12, 24, 48, and 72 hours after surgery

• Post-operative opioid consumptions

  from arrived at PACU to the first 72 post-operative hours

• The changes of NRS of postoperative pain

  at 2, 6, 12, 24, 48, and 72 hours after surgery

• Complications related to general anesthesia

  started from the induction of general anesthesia to the first 72 post-operative hours

• Complications related to combined spinal-epidural anesthesia

  started from the beginning of combined spinal-epidural anesthesia to the first 72 post-operative hours

Study Arms (2)

General anesthesia group

EXPERIMENTAL

Patients in GA group will receive general anesthesia combined with FNB. All patients received routine anesthesia and surgical protocols. GA will be induced by intravenously administering propofol 2-4 mg/kg, cisatracurium 0.2mg/kg, sufentanil 0.2-0.3 μg/kg and maintained with remifentanil at 0.15-0.2 μg/kg/min and 2%-3% sevoflurane to keep bispectral index (BIS) values at 40 - 60. FNB will be performed under ultrasound-guieded and combined with nerve stimulation. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle will be inserted in the lateral to medial direction towards the femoral nerve (FN). As the needle is being advanced toward the FN, the nerve stimulator is set at 1 mA, 0.1-millisecond pulse duration, and 2-Hz frequency. When the muscle contraction of the quadriceps muscle is identified, the current is reduced to 0.5 mA. After the negative aspiration, 20 mL of ropivacaine 0.375% is injected.

Procedure: anesthesia approach (general anesthesia or non-general anesthesia)

Non-general anesthesia group

EXPERIMENTAL

Patients in NGA group will receive combined spinal-epidural anesthesia（CSEA）at L3 to L4 interspace with 3.0 ml of 0.5% hyperbaric ropivacaine followed with FNB , and without sedation. The FNB will be performed under aseptic precautions using ultrasound guidance and nerve stimulation. A high frequency linear ultrasound transducer 5-12 MHz (Sonosite, Inc. Bothell WA 98021 USA) was placed on the inguinal crease to identify the femoral artery and nerve. Using an in-plane technique, a 10-cm long 18- gauge (G) Tuohy needle connected to the nerve stimulator will be inserted in the lateral to medial direction towards the femoral nerve. When the muscle contraction of the quadriceps muscle and negative aspiration are identified, 20 mL of ropivacaine 0.375% is injected. If the CSEA analgesia is invalid (two times of epidural remedial analgesia) , change non-general anesthesia to general anesthesia, and the subjects withdrew from the trial.

Procedure: anesthesia approach (general anesthesia or non-general anesthesia)

Interventions

anesthesia approach (general anesthesia or non-general anesthesia) PROCEDURE

patients in group GA received general anesthesia followed with FNB. patients in group NGA received CSEA followed with FNB

General anesthesia group; Non-general anesthesia group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be scheduled to receive anterior cruciate ligament reconstruction of knee joint for the first time
• American Society of Anesthesiologists (ASA) physical status I or II
• The operation time is less than 2 hours (from the beginning use of the tourniquet to the release)

You may not qualify if:

• Clinical diagnosis of anxiety or depression or mania
• Clinical diagnosis of systemic diseases (systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, primary aldosteronism, Cushing syndrome)
• Medication history of cortisol or sedative hypnotic drugs
• Tumor patients
• Smoking
• Pregnancy status
• Diabetes
• Drinking coffee or alcohol drinks during perioperative period

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

Second Affiliated Hospital of WenZhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

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MeSH Terms

Conditions

Depression; Anxiety Disorders; Fractures, Stress

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• CongCong Huang, Master

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the investigator and the outcomes assessor doing follow-up interviews and extracting data from the electronic medical records will be blinded to group allocation and treatment interventions. The patients know the allocation, cause patients in group NGA will not receive any sedation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized in a 1:1 ratio into two groups, group GA and group NGA, using a random number generator. This allocation will be written and stored in an opaque, secure envelope. Patients in group GA will receive general anesthesia followed by femoral nerve block. Patients in group NGA will receive combined spinal-epidural anesthesia followed by femoral nerve block.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: April 7, 2022
• Study Start: October 20, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 30, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)