Thyroid Disease
Conditions
Brief summary
1. Eligible patients were selected and enrolled in the study. 2. General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction. 3. The patients' pain and cognition are followed up after surgery.
Interventions
DRUGCiprofol
Beginning with an initial target plasma concentration of ciprofol at 1.2 μg/mL. Assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and Bispectral Index (BIS) values are performed every minute until the patient achieves a complete anesthetic state (defined as an MOAA/S score of 0).
Sponsors
Peking University Shenzhen Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-65 years * Scheduled for elective thyroidectomy * ASA physical status classification I-II * Willing to participate and providing written informed consent
Exclusion criteria
* Recent use of sedatives or opioid analgesics * Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance \<35 mL/min ,Requiring preoperative dialysis * Significant cardiovascular comorbidities * Body mass index ≥35 kg/m² or \<18.5 kg/m² * Known hypersensitivity or adverse reactions to propofol/ciprofol * Neuropsychiatric disorders including:Alzheimer's disease,History of cerebrovascular events,Traumatic brain injury,Space-occupying brain lesions,Other significant neurological deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect-site concentration of cipofol, when MOAAS reaches 2 | From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce). | The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 2. (Modified Observer's Assessment of Alertness/Sedation: 5--Responds readily to name spoken in normal tone ； 4--Lethargic response to name spoken in normal tone ； 3--Responds only after name is called loudly and/or repeatedly ； 2--Responds only after mild prodding or shaking ； 1--Responds only after painful trapezius squeeze ； 0--No response after painful trapezius squeeze；) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect-site concentration of cipofol, when MOAA/S reaches 0. | From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce). | The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 0. |
| Bispectral index | From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values. | Bispectral Index (BIS) values corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores. |
| The EC₅₀ and EC₉₅ of ciprofol | From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce). | The EC₅₀ and EC₉₅ of ciprofol corresponding to MOAA/S scores of 2 and 0 |
| Heart rate | From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR. | Heart rate(in bpm) corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores. |
| Blood pressure | From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure. | The systolic blood pressure, diastolic blood pressure and mean arterial pressure corresponding to different MOAAS scores were all recorded. |
Countries
China
Contacts
Primary ContactTao Luo
Outcome results
None listed