Benefits and Risks to Research Subjects


In the pre-anesthesia room:

- Review medical records and preparations.

- Measure heart rate and blood pressure.

- Place intravenous line with 0.9% NaCl, 20G catheter.

- Wear a name tag to avoid confusion.

- Take the patient to the operating room.

2.2.6.2. Performing anesthesia

- Set up non-invasive BP monitoring, SpO 2 , ECG, EtCO 2 .

- Breathe oxygen through the nose 3 liters/minute.

Premedication: common to both groups:

- Midazolam 1 mg diluted by slow IV injection.

- Lidocaine 1%, 0.5 mg/kg body weight, slow IV injection.

Induction: after 1 minute:

- Fentanyl slow IV injection according to weight:

+ ≤50 kg: 100 µg

+ 51-75 kg: 150 µg

+ ≥ 75 kg: 200 µg

- TCI group: place NĐĐ at the site of action (Ce) = 4µg/ml.

Select rapid induction mode, set plasma concentration (Cp) 6 µg/ml higher than brain concentration.

- When the patient loses consciousness (loses response to speech), reduce plasma NDĐ to 4µg/ml. Apply a mask to help breathe with 100% oxygen, 4 liters/minute.

- Record Ce at loss of consciousness and other subsequent times.

BTĐ Group:

- Manually bolus propofol within 20 seconds. Dose: 2.5 mg/kg body weight for patients ≤55 years old, 2 mg/kg body weight for the remaining patients. Immediately switch to maintenance pump mode 10 mg/kg/hour.


Both groups:

- When the patient is eligible for MNTQ placement, proceed to place MNTQ using the index finger method with an assistant pulling the lower jaw. Inflate the cuff, attach the anesthesia machine system to MNTQ, check the tightness of MNTQ by observing the chest, listening to alveolar murmurs on both sides of the lungs, EtCO 2 wave and airway pressure of the meter on the anesthesia machine. Ventilate using volume control method with Vt = 6 - 8 ml/kg body weight, frequency 12 - 14 times/minute, I/E ratio = ½. Maintain EtCO 2 = 28 - 45mmHg, ventilation pressure ≤ 35cmH 2 O, SpO 2 ≥ 98%.

- During the induction of anesthesia, if the patient is eligible for early MNTQ placement, determine the NDĐ or dose at that time to avoid overdose of anesthetic. Conversely, if the patient is not yet anesthetized, increase the NDĐ or induction dose. Each increase is 0.5 µg/ml for the TCI group, or 0.5 mg/kg for the BTĐ group.

- If BP drops, reduce the dose of anesthetic and allow 100ml of fluid to drain rapidly in 2 minutes. If BP remains low, continue to reduce the dose of anesthetic and give 3mg of diluted ephedrine by slow IV injection.

Maintenance of anesthesia: The goal of maintenance of anesthesia is to keep the PRST score < 3.

- TCI group maintained Ce 4 µg/ml. When the patient showed signs of pain (PRST score

≥ 3) then increase the NDĐ, each time 0.5 µg/ml and wait for 2 minutes. Can repeat but not more than 5 µg/ml. When the patient shows signs of deep sleep (PRST score = 0, low blood pressure, slow heart rate), reduce the NDĐ, each time 0.5 µg/ml.

- The BTĐ group maintains 10 mg/kg/hour. When the patient shows signs of wakefulness (PRST score ≥ 3), increase by 0.5 mg/kg/hour each time but not more than 12 mg/kg/hour. When the patient shows signs of deep sleep (PRST score = 0, low blood pressure, slow heart rate), reduce the dose by 0.5 mg/kg/hour each time.

2.2.6.3. End of anesthesia:

- Stop propofol 5 minutes before the end of the intervention.


- Paracetamol 1g bottle (100 ml) IV infusion 120 drops/minute.

- Switch to spontaneous breathing mode for patients with controlled respiration.

- Remove the endotracheal tube in the operating room when the patient opens his eyes as ordered, breathes 10-20 times/minute on his own, has no signs of wheezing or phlegm retention, SpO 2 > 96% breathing room air.

- Patients with OAA/S score 5 are transferred directly to the post-operative room.

surgery


- Pulse, BP and SpO 2 were taken at the following times:

+ T0: receive patient.

+ T1: before anesthesia.

+ T2: loss of consciousness.

+ T3: before placing MNTQ.

+ T4: 1 minute after placing MNTQ.

+ T5: before intervention.

+ T6: intervention for 1 minute.

+ T7: intervention for 5 minutes (during intervention).

+ T8: 5 minutes before the end of the intervention (end of the intervention).

+ T9: wake up.

+ T10: before withdrawing MNTQ.

+ T11: 1 minute after withdrawing MNTQ.


In the recovery room

+ Breathe oxygen through the nose 4 liters/minute.

+ OAA/S sedation score assessment.

+ Evaluate according to Aldrete every 3-5 minutes. When Aldrete score reaches ≥ 9, transfer patient to post-operative room.


In the postoperative room

+ Pain relief with ketorolac 30 mg intramuscular injection and paracetamol 1g (100ml) IV.

+ Evaluate the General F. score every 30-60 minutes. When the General score reaches ≥ 9 points, the patient is allowed to complete discharge procedures.

At patient's home

Phone review:

- Pain, urinary retention, vomiting and nausea, dizziness, hoarseness, sore throat, difficulty swallowing.

- All patients are scheduled for follow-up visits and contacted by phone when assistance is needed.

help.

2.2.7. Data analysis

The data were processed using SPSS 18.0 biological software, with descriptive statistical tests with a value of p<0.05 considered statistically significant.

Test for differences using the χ 2 statistical test to compare 2 proportions and estimate the relative risk RR with 95% confidence intervals, t-test, non-parametric test or Anova to compare 2 or more mean variables. Use linear regression analysis and Spearman correlation coefficient to find the relationship between variables.

Results are presented as frequencies, proportions, and means and standard deviations in tables and graphs.

2.2.8. Ethics in research

The research process always complies with the operating regulations of the Ethics Council in biomedical research according to Decision No. 5129/2002/QD - YT dated December 19, 2002 of the Minister of Health.


2.2.8.1. Benefits and risks to research subjects

In this study, selected patients will be fully anesthetized with propofol with or without KSNDĐ, ventilated by MNTQ without using muscle relaxants. Therefore, it is very suitable for PTNT.

2.2.8.2. Commitment to voluntarily agree to participate in research

Patients are selected only when they agree and sign the Voluntary Informed Consent Form to participate in the study. They are informed about the objectives of the study, the benefits and risks, the rights and responsibilities as well as the responsibilities of the researcher. Patients have the right to refuse to participate without discrimination.

2.2.8.3. Information security

The patient's personal information is kept confidential and is only used for this research. The patient's name and personal information will not be published in research results published in scientific journals or reports at other scientific conferences.

The topic has been accepted by the Scientific Council and the Medical Ethics Council of Ho Chi Minh City University of Medicine and Pharmacy Hospital.


2.2.9. Research diagram


Not achieved

Maintain

Achieved: PRST < 3

stable pulse and blood pressure

Increase NDĐ by 0.5 µg/ml each time

Reduce NDĐ by 0.5 µg/ml each time

Assess anesthesia level by PRST, pulse and blood pressure

PRST ≥ 3

HA > baseline value + 15 Pulse > baseline value + 15

Too deep

2.2.9.1. TCI Group


Premedication: Midazolam 1mg

Induction of anesthesia: Fentanyl 1-1.5µg/kg plasma concentration 6µ/ml

Maintain Ce: 4µg/ml.




Assess anesthesia level by PRST, pulse and blood pressure

PRST ≥ 3

HA > baseline value + 15 Pulse > baseline value + 15

Maintain

Achieved: PRST <3

stable pulse and blood pressure

Increase infusion rate by 0.5 mg/kg each time

Too deep

2.2.9.2. BTĐ Group



Premedication: Midazolam 1mg

Induction of anesthesia: Fentanyl 1-1.5µg/kg

Propofol 2-2.5mg/kg bolus

Maintenance: 10mg/kg/hr


Not achieved



Reduce infusion rate by 0.5 mg/kg each time

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Benefits and Risks to Research Subjects



Chapter 3

RESEARCH RESULTS


3.1. PATIENT CHARACTERISTICS AND INTERVENTIONS


3.1.1. Patient characteristics


Table 3.1. Gender, age, weight and BMI



Characteristic

TCI Group


(n = 60)

BTĐ Group


(n = 60)

p


Gender

Male (number of cases, %) Female (number of cases, %)

33 (55.0)


27 (45.0)

32 (53.3)


28 (46.7)


> 0.05

Year old


(year)


X SD


Min-Max

46.5 ± 12.9


21-70

45.2 ± 12.7


21-70


> 0.05

Weight


(kg)


X SD


Min-Max

58.6 ± 8.6


44-77

58.9 ± 9.2


40-80


> 0.05

BMI

(kg/m 2 )


X SD


Min-Max

22.7 ± 2.9


16.9 - 29.7

22.7 ± 2.8


17.1 - 29.3


> 0.05


Comments: There were no statistically significant differences in gender, age, weight and BMI between the two study groups.

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