Health TrialsbyHealthPanel

The Effective Blood Concentration of Ciprofol

ConditionThyroid Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorPeking University Shenzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-65 years

Scheduled for elective thyroidectomy

ASA physical status classification I-II

Willing to participate and providing written informed consent

Disqualifiers

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

Trial population

Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ciprofol

    Drug

    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).

Treatment groups

101 Participants
are divided into 1 treatment group
Group A: ciprofol group1 intervention

Trial outcomes

Primary outcomes

1

The effect-site concentration of cipofol, when MOAAS reaches 2

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；)

Time frame
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).

Secondary outcomes

1

The effect-site concentration of cipofol, when MOAA/S reaches 0.

The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 0.

Time frame
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).
2

Bispectral index

Bispectral Index (BIS) values corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.

Time frame
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.
3

The EC₅₀ and EC₉₅ of ciprofol

The EC₅₀ and EC₉₅ of ciprofol corresponding to MOAA/S scores of 2 and 0

Time frame
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).
4

Heart rate

Heart rate(in bpm) corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Shenzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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