The Effective Effect-Site Propofol Concentration for Induction and Intubation for Schnider Model in Parturients

C.Delivery; Surgery (Previous), Gynecological Clinical Trial

Official title:

The Effective Effect-Site Propofol Concentration for Induction and Intubation for Schnider Model in Parturients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02554175
• Other study ID #: TTWang
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2015
• Last updated: September 17, 2015
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Fudan University
• Contact: Shen Sun
• Email: sunshen1980[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to determine the target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic adverse effects associated with these propofol target concentrations.

Description:

The temperature was maintained at 22˚ C in the operating room. Patients were placed supine with 15°left lateral tilt achieved using a wedge under the right buttock. Electrocardiograph (ECG), pulse oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were monitored by one anesthesiologist (S/5 Anesthesia Monitor, GE Healthcare, Helsinki, Finland), and Bispectral Index (BIS) values (A2000 BIS® XP monitor, version 3.2; Aspect Medical Systems Inc., Newton, MA) were obtained and recorded. The BIS smoothing time period was set at 15 seconds. The mean values of the above-mentioned parameters were recorded at 3-min intervals for three consecutive times to determine baseline values. Peripheral vein catheterization on the right hand was then performed but no prehydration was given. A fixed volume of 500 mL hydroxyethyl starch solution was infused at the rate of 0.2 ml.kg-1.min-1, then Lactated Ringer's solution was infused at the same rate until the end of surgery.

Using a computer-generated random-number sequence, patients were allocated to 1 of 6 groups of predefined propofol target Ce for induction, namely, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 µg.mL-1. General anesthesia was induced with fentanyl 3 µg.kg-1. Propofol was administered by the TCI device to achieve the predetermined target propofol Ce. Loss of consciousness was defined by the disappearance of the eyelash reflex that was assessed every 5 seconds after patients spontaneously closed their eyes. After loss of consciousness, succinylcholine 1.5 mg.kg-1 was administered and tracheal intubation was performed 1 minutes later only if the BIS value was <60 and target propofol Ce had been reached. After intubation, patients were connected to mechanical ventilation adjusted to obtain an end-tidal CO2 of 30 to 35 mm Hg and the propofol target concentration was reduced to 3µg.mL-1. Anesthesiologists performing loss of consciousness assessment and intubation were blinded to the target propofol Ce. SpO2, SBP, DBP, MAP and HR were recorded once a minute for 10 min until 5 minutes after tracheal intubation when the study finished.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Thirty-six women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.

Exclusion Criteria:

• Diabetes controlled by insulin

• Preeclampsia

• Heart diseases

• History of taking drugs potentially affecting cardiovascular system.

• Patients fasted for at least 8 hours before surgery and no premedication was given

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• C.Delivery; Surgery (Previous), Gynecological

Intervention

Drug:
• Propofol
Propofol was administered to achieve target propofol Ce

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients		up to 24 months	Yes