Effect of Total Intravenous Anaesthesia With Propofol on Postoperative Pain After Bilateral Third Molar Surgery

NCT03058341 | Completed Phase 4 DMC

• 1 other identifier: UW16-554
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Some of the advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, better wake up profile and a more favourable intracranial physiology. However, the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are some reasons that preclude more common use. Postoperative dental pain produces an inflammatory pain model. Since propofol has anti-inflammatory effects, it may have significant analgesic effects in patients undergoing dental surgery. To the best of our knowledge, there are no randomized controlled trials comparing the effects of TIVA propofol and inhalational anaesthetic on postoperative dental pain. The aim of this study is to investigate the effect of TIVA propofol on postoperative pain scores, analgesic consumption, and adverse effects in patients undergoing dental surgery. This will help determine whether propofol may be a useful analgesic adjunct in dental surgery.

Conditions

Postoperative Pain

Keywords

postoperative pain; propofol; TIVA

Outcome Measures

Primary Outcomes (1)

• pain score

  measure pain scores at rest and mouth opening using numeral rating scale

  up to postoperative day 3

Secondary Outcomes (7)

• analgesic consumption

  up to postoperative day 3

• side effects of analgesics used

  up to postoperative day 3

• intraoperative vital signs

  during surgery

• intraoperative vital signs

  during surgery

• intraoperative vital signs

  during surgery

Study Arms (2)

Group S

SHAM COMPARATOR

Patients will be anaesthetized by inhalational anaesthesia using sevoflurane.

Drug: Sevoflurane

Group P

EXPERIMENTAL

Patients will be anaesthetized using total intravenous propofol.

Drug: propofol

Interventions

propofol DRUG

Monitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%.

Group P

Sevoflurane DRUG

Propofol 1.5-3mg/kg, remifentanil 0.5-1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously (IV) for induction of general anaesthesia. Otrivin can be applied nasally at the discretion of the anaesthetist. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to keep a BIS value of 40-60. Intravenous remifentanil infusion between 0.1-0.25mcg/kg/min will be given and this will be titrated to optimal haemodynamic parameters. Muscle relaxants can be given during the operation as required.

Group S

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to III
• Age 18 to 80 years old
• Scheduled for elective extraction of impacted bilateral third molar teeth under general anaesthesia in Queen Mary hospital.

You may not qualify if:

• Known drug allergy to propofol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol.
• Alcohol or drug abuse
• Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
• Patients with liver dysfunction (Plasma bilirubin over 34 micromol/L, INR over 1.7, ALT and AST over 100U/L)
• Impaired or retarded mental state
• BMI \> 35kg/m2
• History of chronic pain
• Pregnancy
• Local infection
• Patient refusal

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Stanley SC Wong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will not be informed about what type of anaesthesia they will receive. A separate investigator assessing the patients for data collection after the operation will be blinded. The anaesthetist providing general anaesthesia will not be involved in data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients in the first group (S) will be anaesthetized by inhalational anaesthesia using sevoflurane. The patients in the second group (P) will be anaesthetized using total intravenous propofol.

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 20, 2017
• Study Start: December 23, 2016
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

HK (1)