Anesthetic Optimization in Scoliosis Surgery

Postoperative Pain Clinical Trial

— AIS  

Official title:

Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481570
• Other study ID #: IRB201500120
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 15, 2017

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.

Description:

As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 15, 2017
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) class 1-2

• At least 10 years of age and not older than 18 years of age

• Diagnosis of idiopathic adolescent scoliosis

Exclusion Criteria:

• Currently pregnant

• Currently breastfeeding

• Currently being treated with opiates

• Currently being treated with alpha2 agonists

• Currently being treated with anticonvulsants

• Currently being treated with antidepressants

• History of significant restrictive lung disease

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Pain, Postoperative
• Postoperative Pain
• Respiratory Depression
• Respiratory Insufficiency
• Scoliosis

Intervention

Other:
• pharmacokinetic simulation
The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-Item Pain Intensity Measure	0 - 10 (0=no pain; 10 = pain as bad as can be)	24 hours
Primary	Respiratory depression	Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.	24 hours
Secondary	Utility of pharmacokinetic simulation	The number of modifications to the anesthetic dosing	4 - 8 hours (Intraoperative period)