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

Dexmedetomidine Combined With Nalbuphine Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthetics，Emergence Agitation
• Intervention / Treatment: Drug: Nalbuphine，dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tian Jin First Center Hospital
    • Contact: Wenli Yu; Phone Number: 13920098326; Email: yzxyuwenli@163.com
  • Tianjin
    • Tianjin, Tianjin, China, 300192
      • Recruiting
      • Tianjin First Central Hospital
      • Contact: Lili Jia; Phone Number: +8613102058301; Email: jialili19880801@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEX and Nalbuphine group; 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.	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; 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	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.
Experimental: nalbuphine group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from the time of awakening to 30 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperation pain	Postoperative pain was assessed by visual analogue scale (VAS) at 0, 10, 20 and 30min after extubation by PACU.	from the time of awakening to 30 minutes after extubation
Postoperative cough	Grade of choking	from the time of awakening to 30 minutes after extubation

Collaborators and Investigators

• Sponsor: Lili Jia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Nalbuphine
• Other Study ID Numbers: 2023TJY

Drug and device information, study documents

• 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