The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery

NCT04596774 | Completed

• 1 other identifier: 2020/965
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Orthognathic surgeries are generally associated with blood loss, swelling, postoperative nausea vomiting (PONV), and pain. The aim of this study is to improve postoperative outcome in patients undergoing orthognatic surgeries by the use of Enhanced Recovery After Surgery (ERAS) protocols. Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis and patient controlled analgesia was added to the routine plans for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, length of postanesthesia care unit (PACU) stay, numeric rating scale (NRS) pain scores, opioid consumption and PONV incidences through the postoperative first 48 hours, and satisfaction scores.

Conditions

Enhanced Recovery After Surgery; Hospital Stay; Postoperative Nausea and Vomiting; Pain, Postoperative

Keywords

Orthognathic surgery; Enhanced recovery after surgery (ERAS); Analgesia; Postoperative nausea vomiting (PONV); Satisfaction

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)

  0-48 hours

Secondary Outcomes (14)

• Mean arterial pressure (MAP)

  0-5 hours

• Heart rate

  0-5 hours

• Intraoperative fentanyl requirement

  0-5 hours

• The amount of blood loss

  0-5 hours

• The difference of preoperative-postoperative haemoglobin values

  0-12 hours

Study Arms (2)

Group 1

Group 1 patients were applied traditional approach. Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.

Procedure: Traditional Approach

Group 2

Group 2 received Enhanced Recovery After Surgery (ERAS) approach. Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours.

Procedure: Enhanced Recovery After Surgery (ERAS) Approach

Interventions

Traditional Approach PROCEDURE

Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.

Group 1

Enhanced Recovery After Surgery (ERAS) Approach PROCEDURE

Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours.

Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for orthognathic surgery Patients who were operated under either the traditional approach or the Enhanced Recovery After Surgery (ERAS) approach Patients aged between 18 and 40 years of age American Society of Anesthesiologists (ASA) physical status of 1-2

You may qualify if:

• Patients undergoing orthognathic surgery (bimaxillary, mandibular/maxillary)
• Patients aged between 18 and 40 years of age
• American Society of Anesthesiologists (ASA) physical status of 1-2
• Capable of understanding the instructions for using the NRS pain scores
• Capable of replying the study-based questions
• Absence of mental/psychiatric disorders
• Absence of chronic analgesic/opioid use
• Absence of alcohol/illicit drug use

You may not qualify if:

• Patients who are younger than 18 years of age
• Patients who are older than 45 years of age
• American Society of Anesthesiologists (ASA) physical status of 3-4
• Not capable of consenting
• Not capable of understanding the instructions for using the NRS pain
• scores
• Not capable of replying the study-based questions
• Presence of mental/psychiatric disorders
• Presence of chronic analgesic/opioid use
• Presence of alcohol/illicit drug use

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (4)

• Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1.

  PMID: 29301675 RESULT

• Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25.

  PMID: 27542543 RESULT

• Mobini A, Mehra P, Chigurupati R. Postoperative Pain and Opioid Analgesic Requirements After Orthognathic Surgery. J Oral Maxillofac Surg. 2018 Nov;76(11):2285-2295. doi: 10.1016/j.joms.2018.05.014. Epub 2018 May 19.

  PMID: 29886112 RESULT

• Agbaje J, Luyten J, Politis C. Pain Complaints in Patients Undergoing Orthognathic Surgery. Pain Res Manag. 2018 Jul 15;2018:4235025. doi: 10.1155/2018/4235025. eCollection 2018.

  PMID: 30123397 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative; Agnosia; Personal Satisfaction

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Emine A Salviz, MD,AssocProf

  Study Principal Investigator, Corresponding author

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Attending Anesthesiologist, Associate Professor

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 22, 2020
• Study Start: August 1, 2018
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)