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The effect of lidocaine on paresthesia induced by injection of fospropofol disodium during general anesthesia induction: a randomized controlled trial

The effect of lidocaine on paresthesia induced by injection of fospropofol disodium during general anesthesia induction: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071330
Enrollment
Unknown
Registered
2023-05-11
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paresthesia

Interventions

Interventional group:lidocaine+fospropofol disodium
Control group:fospropofol disodium

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 65 years old = 18 years old, BMI=18-30kg/m2, ASA I-III; (2) Patients undergoing elective general anesthesia surgery and requiring tracheal intubation for non cardiothoracic and non extracerebral surgeries; (3) No mental illness, chronic itching, or sensory abnormalities; (4) Sign an informed consent form and agree to be included in the study.

Exclusion criteria

Exclusion criteria: (1) Individuals with contraindications to general anesthesia or those who have experienced anesthesia accidents in the past; (2) Those who need to combine other anesthesia methods besides general anesthesia, such as epidural anesthesia, subarachnoid anesthesia, nerve block, etc; (3) Individuals with difficult airways or diagnosed with difficulty in tracheal intubation (modified Markov score of III or IV) (4) Concomitant neurological and psychiatric disorders: such as craniocerebral injury, intracranial hypertension, stroke, or previous history of mental illness; (5) Abnormal liver function (ALT or AST = 2.5 times the upper limit of normal value, TBIL = 1.5 times the upper limit of normal value), abnormal renal function (Cr>the upper limit of normal value, or dialysis treatment within 28 days before surgery); Uncontrolled diabetes or hypertension; (6) Individuals with allergies or contraindications to experimental drugs or other anesthetic drugs; (7) Individuals who have participated in any drug clinical trial within one month prior to screening; (8) The researchers believe that subjects with any other unfavorable factors for participating in this experiment.

Design outcomes

Primary

MeasureTime frame
rate of paresthesia;

Secondary

MeasureTime frame
VRS score of pruritus;Pain at the administration site;Duration of disappearance of eyelash reflex;The incidence of hypotension and bradycardia during anesthesia induction period;Blood pressure, heart rate and BIS during anesthesia induction;Success rate of anesthesia induction;Vital signs during anesthesia maintenance period;Recovery period related indicators;Perioperative adverse reactions;the first administration time of maintain medication;blood sample test;

Countries

China

Contacts

Public ContactChen Chan

West China Hospital of Sichuan University

xychenchan@gmail.com+86 189 8060 6260

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026