Influence of Anesthetic Drugs on Extubation After General Anesthesia

Sponsor
Lili Jia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05769530
Collaborator
(none)
360
2
2
16
180
11.3

Study Details

Study Description

Brief Summary

Recovery period of general anesthesia refers to the period from the end of anesthesia infusion to recovery of the patient after the operation. In patients with general anesthesia, the depth of anesthesia is reduced in the early stage of recovery, the cerebral cortex is still in a state of inhibition, and the subcortical center is often in a state of high sensitivity to external stimulation. At this time, due to drug effects, pain, hypoxemia, undetected aspiration, pneumothorax, urinary retention, tracheal catheter stimulation, urinary tube stimulation and other factors, the patient will be induced to appear restless reaction, and cause drastic changes in hemodynamics. Especially for the elderly with organ dysfunction, it may increase postoperative complications, prolong hospital stay and increase hospital costs.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

In recent years, a number of studies have shown that dexmetropil and nalbuphine can reduce postoperative agitation and cough during extubation, respectively, without increasing extubation time. Nalbuphine is a combination of opioid receptor excitation-antagonistic analgesic, which can be combined with μ, κand δ receptors. Nalbuphine has complete excitatory effect on κreceptor and partial antagonistic effect on μ receptor, so it has analgesic and sedative effect. Its analgesic intensity is similar to that of morphine, which can be used to relieve moderate to severe pain and also reduce visceral pain. With little addiction, it can effectively prevent anesthetic stimulation caused by surgical trauma and reduce intraoperative inflammation. Nalbuphine has few cardiovascular side effects, mild respiratory depression and capping effect. As with other agonist antagonists, nabulphine interferes with the adverse reactions associated with pure μ-receptor agonists, such as nausea, vomiting, and pruritus. Dexmedetomidine belongs to an agonist of α2 adrenergic receptor, which has analgesic, sedative, antianxiety, stable kinetics and reducing stress response. It can activate the α2 receptor in the patient's body, thus inhibiting the release of norepinephrine in the patient's body, and then play a role in analgesia, sedation, anti-anxiety.

The main result of this study was the occurrence of agitation within 30 minutes after general anesthesia. The occurrence of agitation was determined by the Riker sedation-excitement score (5-7).

Secondary research indicators:
  1. EA occurred 0, 10, 20, 30 minutes after extubation by PACU.

  2. Chills occurred 0, 10, 20, 30 minutes after extubation in PACU.

  3. Postoperative pain was assessed by visual analogue scale (VAS) at 0, 10, 20 and 30min after extubation by PACU.

  4. Classification of choking degree within 30 minutes after extubation after recovery

  5. The changes of vital signs (heart rate, blood pressure and oxygen saturation) were observed at 0min, 10min, 20min and 30min after extubation.

  6. extubation time: the time from anesthetic withdrawal to extubation.

  7. Length of hospital stay in PACU: the duration from the end of the operation to the exit of PACU.

  8. Oxygenation index: The radial artery blood was taken for blood gas analysis before incision, after surgery and 5 minutes after extubation, and the oxygenation index (PaO2/FiO2) was calculated.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effect of Intravenous Anesthesia on Extubation Response After General Anesthesia Operation
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug intervention group

In group B, DEX 0.5μg/kg was injected intravenously during the operation, which was completed in 10 min, and Nalbuphine 0.20 mg/kg (5 mL) was injected intravenously 30min before the end of the operation. After the operation, all anesthetic drugs were stopped and the patient was transferred to PACU with intubation. The main result of this study was the occurrence of agitation within 30 minutes after general anesthesia. The occurrence of agitation was determined by the Riker sedation-excitement score (5-7).

Drug: Nalbuphine,dexmedetomidine
According to the drug use, the subjects were divided into group A, which was continuously injected with normal saline during the operation, and intravenously injected with 5 mL normal saline 30 minutes before the end of the operation. In group B, DEX 0.5μg/kg was injected intravenously during the operation, which was completed in 10 min, and Nalbuphine 0.20 mg/kg (5 mL) was injected intravenously 30min before the end of the operation. After the operation, all anesthetic drugs were stopped and the patient was transferred to PACU with intubation.

Placebo Comparator: placebo group

According to the drug use, the subjects were divided into group A, which was continuously injected with normal saline during the operation, and intravenously injected with 5 mL normal saline 30 minutes before the end of the operation.

Drug: Nalbuphine,dexmedetomidine
According to the drug use, the subjects were divided into group A, which was continuously injected with normal saline during the operation, and intravenously injected with 5 mL normal saline 30 minutes before the end of the operation. In group B, DEX 0.5μg/kg was injected intravenously during the operation, which was completed in 10 min, and Nalbuphine 0.20 mg/kg (5 mL) was injected intravenously 30min before the end of the operation. After the operation, all anesthetic drugs were stopped and the patient was transferred to PACU with intubation.

Outcome Measures

Primary Outcome Measures

  1. The main outcome of this study was the occurrence of agitation from the time of awakening to 30 minutes after extubation [from the time of awakening to 30 minutes after extubation]

    Riker sedation-excitement score, 5 to 7 points to determine the occurrence of agitation.

Secondary Outcome Measures

  1. postoperation pain [from the time of awakening to 30 minutes after extubation]

    Postoperative pain was assessed by visual analogue scale (VAS) at 0, 10, 20 and 30min after extubation by PACU.

  2. Postoperative cough [from the time of awakening to 30 minutes after extubation]

    Grade of choking

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • (1) Age ≥55, gender unlimited;

(2) ventilator assisted ventilation after endotracheal intubation;

(3) General anesthesia surgery;

Exclusion Criteria:
  • (1) Allergy to the drugs used in this study;

(2) any sedative, analgesic, antiemetic or antipruritic drugs taken 24 hours before the operation;

(3) History of severe bradycardia (heart rate < 50 beats/min);

(4) moderate to severe hepatic and renal dysfunction;

(5) Patients with neurological diseases;

Contacts and Locations

Locations

Site City State Country Postal Code
1 TianJin First Central Hospital Tianjin Tianjin China 300192
2 Tian Jin First Center Hospital Tianjin China

Sponsors and Collaborators

  • Lili Jia

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Lili Jia, sponsor, Tianjin First Central Hospital
ClinicalTrials.gov Identifier:
NCT05769530
Other Study ID Numbers:
  • 2023TJY
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023