Skip to content

A study of the relationship of the SPI index and the effect-site concentration of the remifentanil during the period of the tracheal intubation

A study of the relationship of the SPI index and the effect-site concentration of the remifentanil during the period of the tracheal intubation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOD-16008381
Enrollment
Unknown
Registered
2016-04-28
Start date
2016-05-02
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hepatobilliary disease and appendix disease

Interventions

R1 group:the effect-site concentration of the remifentanil is 2.5ng/ml
R2 group:the effect-site concentration of the remifentanil is 3.0ng/ml
R3 group:the effect-site concentration of the remifentanil is 3.5ng/ml
R4 group:the effect-site concentration of the remifentanil is 4.0ng/ml
R5 group:the effect-site concentration of the remifentanil is 4.5ng/ml
R6 group:the effect-site concentration of the remifentanil is 5.0ng/ml
R7 group:the effect-site concentration of the remifentanil is 5.5ng/ml
R8 group:the effect-site concentration of the remifentanil is 6.0ng/ml
R9 group:the effect-site concentration of the remifentanil is 6.5ng/ml
R10 group:the effect-site concentration of the remifentanil is 7.0ng/ml

Sponsors

Xuanwu Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing scheduled surgery in Xuanwu Hospital of Capital Medical University; 2. All genders; 3. Aged 18-65 years old; 4. ASA physical status 1 or 2; 5. Surgery including laparoscopic cholecystectomy, laparoscopic choledocholithotomy, appendectomy, laparoscopic liver cyst fenestration, hapatic hemangioma resection; 6. Undergoing endotracheal intubation; 7. BMI<30; 8. Mallampati classification 1-2.

Exclusion criteria

Exclusion criteria: 1. The patient's too old or too young; 2. Patient's undergoing emergency surgery; 3. ASA physical status >=III; 4. Any history including psychiatric disease, disease causing chronic pain(for instance, chronic sciatica), endocrine disease (patients suffering from diabetes are excluded no matter how well the blood sugar is controlled), hypertension more than grade 1, central neurological disease, analgesic drug abuse (including NSAIDs), chronic self-immune diseases (prevent the disease from getting worse, however, local immune diseases like the Spring Catarrhal Conjunctivitis are not included); 5. Blood pressure dropped for more than 20% of the basic value; 6. Mallampati classification >=3.

Design outcomes

Primary

MeasureTime frame
SPI index when entering the OR;heart rate when entering the OR;blood pressure when entering the OR;bispectrl index when entering the OR;heart rate when BIS maintains at 50±5;blood pressure when BIS maintains at 50±5;SPI index when BIS maintains at 50±5;BIS value when BIS maintains at 50±5;heart rate when the neuromuscular block reaches the maximum effect;blood pressure when the neuromuscular block reaches the maximum effect;SPI index when the neuromuscular block reaches the maximum effect;BIS value when the neuromuscular block reaches the maximum effect;heart rate when the remifentanil reaches the effect site concentration;blood pressure when the remifentanil reaches the effect site concentration;SPI index when the remifentanil reaches the effect site concentration;BIS value when the remifentanil reaches the effect site concentration;the maximum heart rate after intubation;the maximum blood pressure after intubation;the maximum SPI index after intubation;the maximum BIS value after intubation;heart rate after incision;blood pressure after inscision;SPI index after incision;BIS value after insicion;heart rate after the pneumoperitoneum is built;blood pressure after the pneumoperitoneum is built;SPI index after the pneumoperitoneum is built;BIS value after the pneumoperitoneum is built;heart rate after the Trocar is inserted;blood pressure after the Trocar is inserted;SPI index after the Trocar is inserted;BIS value after the Trocar is inserted;heart rate before incision;blood pressure before incision;BIS value before incision;SPI index before the incision;blood pressure before the pneumoperitoneum is built;heart rate before the pneumoperitoneum is built;BIS value before the pneumoperitoneum is built;SPI index before the pneumoperitoneum is built;heart rate before the Trocar is inserted;blood pressure before the Trocar is inserted;BIS value before the Trocar is inserted;SPI index before the Trocar is inserted;

Secondary

MeasureTime frame
the time duration from the anesthesia begining to operation start;the time duration of the intubation;the time duration for the systolic pressure under 80mmHg;the time duration for the systolic pressure over 20% of the basic value;the time duration for the heart rate faster than 20% of the basic value;the time duration for the heart rate lower than 45 beats/min;the time duration of the surgery;Numerical Rating Scale;postoperative pharynaglgia;postoperative trachyphonia;

Countries

China

Contacts

Public ContactWang Tian-long

the Department of Anesthesiology and Operating Theatre, Xuanwu Hospital of Capital Medical University

w_tl5595@hotmail.com+86 13910525304

Outcome results

None listed

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