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Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients

Primary Purpose

General Anesthetics,Emergence Agitation

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nalbuphine,dexmedetomidine
Sponsored by
Lili Jia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for General Anesthetics,Emergence Agitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) Age ≥60, 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;

Sites / Locations

  • TianJin First Central Hospital
  • Tian Jin First Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

DEX and Nalbuphine group

placebo group

nalbuphine group

Arm Description

In group B, DEX 0.5μg/kg was injected intravenously 30min before the end of the operation, 30min after the pump, and Nalbuphine 0.20 mg/kg (5 mL) was injected intravenously 30min before the end of the operation.

Group A was continuously injected with normal saline during the operation, and 5 mL of normal saline was injected intravenously 30min before the end of the operation

Group C was continuously injected with normal saline 30 minutes before the end of the operation, and intravenous injection of nalbuphine 0.20 mg/kg (5 mL) 30 minutes before the end of the operation.

Outcomes

Primary Outcome Measures

The main outcome of this study was the occurrence of agitation 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

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

Full Information

First Posted
March 3, 2023
Last Updated
May 17, 2023
Sponsor
Lili Jia
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1. Study Identification

Unique Protocol Identification Number
NCT05769530
Brief Title
Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients
Official Title
Dexmedetomidine Combined With Nalbuphine Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lili Jia

4. Oversight

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

5. 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.
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: EA occurred 0, 10, 20, 30 minutes after extubation by PACU. Chills occurred 0, 10, 20, 30 minutes after extubation in PACU. Postoperative pain was assessed by visual analogue scale (VAS) at 0, 10, 20 and 30min after extubation by PACU. Classification of choking degree within 30 minutes after extubation after recovery The changes of vital signs (heart rate, blood pressure and oxygen saturation) were observed at 0min, 10min, 20min and 30min after extubation. extubation time: the time from anesthetic withdrawal to extubation. Length of hospital stay in PACU: the duration from the end of the operation to the exit of PACU. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthetics,Emergence Agitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEX and Nalbuphine group
Arm Type
Experimental
Arm Description
In group B, DEX 0.5μg/kg was injected intravenously 30min before the end of the operation, 30min after the pump, and Nalbuphine 0.20 mg/kg (5 mL) was injected intravenously 30min before the end of the operation.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Group A was continuously injected with normal saline during the operation, and 5 mL of normal saline was injected intravenously 30min before the end of the operation
Arm Title
nalbuphine group
Arm Type
Experimental
Arm Description
Group C was continuously injected with normal saline 30 minutes before the end of the operation, and intravenous injection of nalbuphine 0.20 mg/kg (5 mL) 30 minutes before the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Nalbuphine,dexmedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The main outcome of this study was the occurrence of agitation from the time of awakening to 30 minutes after extubation
Description
Riker sedation-excitement score, 5 to 7 points to determine the occurrence of agitation.
Time Frame
from the time of awakening to 30 minutes after extubation
Secondary Outcome Measure Information:
Title
postoperation pain
Description
Postoperative pain was assessed by visual analogue scale (VAS) at 0, 10, 20 and 30min after extubation by PACU.
Time Frame
from the time of awakening to 30 minutes after extubation
Title
Postoperative cough
Description
Grade of choking
Time Frame
from the time of awakening to 30 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Age ≥60, 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;
Facility Information:
Facility Name
TianJin First Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Jia
Phone
+8613102058301
Email
jialili19880801@163.com
Facility Name
Tian Jin First Center Hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenli Yu
Phone
13920098326
Email
yzxyuwenli@163.com

12. IPD Sharing Statement

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Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients

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