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

NCT05769530 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2023TJY
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

General Anesthetics，Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• postoperation pain

  from the time of awakening to 30 minutes after extubation

• Postoperative cough

  from the time of awakening to 30 minutes after extubation

Study Arms (3)

DEX and Nalbuphine group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

nalbuphine group

EXPERIMENTAL

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

Interventions

Nalbuphine，dexmedetomidine DRUG

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.

DEX and Nalbuphine group; nalbuphine group; placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Age ≥60, gender unlimited;
• (2) ventilator assisted ventilation after endotracheal intubation;
• (3) General anesthesia surgery;

You may not qualify if:

• (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;

Sponsors & Collaborators

• Lili Jia: lead

Study Sites (2)

TianJin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

RECRUITING

Tian Jin First Center Hospital

Tianjin, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: sponsor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

CN (2)