Differences in Speed of Recovery From Anesthesia for Intraoral Surgery (PSIOS)

April 19, 2024 updated by: Ivan Šitum, MD, Clinical Hospital Centre Zagreb

Differences in Speed of Recovery From Anesthesia and Recovery of Muscle Strength in General Balanced Inhalation Anesthesia and Total Intravenous Anesthesia for Intraoral Surgery - Clinical Randomised Trial

The goal of this clinical trial is to compare two groups of patients going in general anesthesia for intraoral surgery, the first group TIVA with propofol and the second group inhalational with sevoflurane. The main questions it aims to answer are to asses speed and quality of recovery from general anesthesia.

Participants will fill out a questionnaire to evaluate the quality of recovery from anesthesia using the QoR-40 1h, 24h, and 30 days after waking up from anesthesia in comparison to the results of the same questionnaire before surgery. Also, the investigators will perform a hand grip and bite strength test on the patients after waking up from anesthesia in the operating room, after 1 hour in the recovery room, and after 24 hours compared to preoperative values.

The investigators will compare TIVA and Volatile groups to see if there are any differences in recovery seed, muscle strength recovery, postoperative nausea and vomiting, and shivering between groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After obtaining the approval of the ethics committee of KBC Zagreb and the Faculty of Dentistry of the University of Zagreb, the research will be conducted at KBC Zagreb.

Criteria for patient inclusion are:

  • patients older than 18 years
  • ASA status 1-3,
  • Patients who have an indication for an intraoral surgical procedure longer than 30 minutes.
  • patients who agreed to the research and signed the consent

Exclusion criteria are:

  • ASA status higher than 3,
  • the need for postoperative care in the ICU,
  • surgery lasting more than 2 hours,
  • known allergies to drugs used in the trial,
  • refusal to participate Participants will be randomly divided according to a predetermined randomization table (32) into the TIVA group and the Volatile group. After identification of the participants in the operating room, participants will be fitted with a peripheral venous line, electrocardiogram monitoring, non-invasive blood pressure measurement, pulse oximeter, capnograph, temperature probe, and bispectral index (BIS) of the electroencephalogram and neuromuscular monitoring, kinemiography with train-of-four (TOF , M-NMT, Drägerwerk AG & Co. KGaA,) by recording the responses.

The initial anesthesiological induction procedure will not differ in both groups of patients. The drugs that will be used are sufentanil 0.3mcg/kg, propofol 2mg/kg, and cisatracurium 0.1mg/kg.

Participants will be intubated with an endotracheal tube and mechanically ventilated with a mixture of oxygen and air (inspiratory fraction of oxygen 40%) with a total flow of gas mixture of 3 L/min.

Anesthesia will be maintained in the volatile group with the inhaled anesthetic sevoflurane and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.

In the TIVA group, anesthesia will be maintained with a continuous infusion of propofol (5-10 mg/kg/h) and single doses of cisatracurium. Cisatracurium will be repeated when the TOF ratio is greater than 5%, and the repeat dose will be 0.01 mg/kg. The depth of anesthesia will be controlled by BIS, maintaining values between 25 and 50. Recommended drug doses will be guided by TOF and BIS values.

At the end of the surgical intervention in both groups, the neuromuscular block will be antagonized with prostigmine (0.05 mg/kg) along with atropine (0.01 mg/kg) as soon as the patient begins to breathe spontaneously. Patients will then be extubated when the TOF index is greater than 90%

Muscle strength of all participants will be measured with a JAMAR hand dynamometer, and bite force with a gnathodynamometer (Bite force sensor, Monad electronics) in four time intervals:

  1. Before introduction to anesthesia
  2. After waking up from anesthesia in the operating room
  3. 1 hour after waking up from anesthesia in the recovery room
  4. After 24 hours from the operation

All patients will fill out the Quality of recovery-40 (Qor-40) questionnaire for assessing the quality of recovery after anesthesia and surgery in four time intervals:

  1. Before introduction to anesthesia
  2. 1 hour after waking up from anesthesia in the recovery room
  3. After 24 hours from the operation
  4. After 30 days from the operation Consent for the use of the QoR-40 questionnaire was obtained by the main researcher from the author, Professor P.S. Myles, and Dr. M. Miklić Bublić, who translated the questionnaire into Croatian.

Postoperative nausea and vomiting and postoperative shivering will also be recorded.

In the perioperative period, all participants will be placed in the department of otorhinolaryngology and head and neck surgery, where they will all receive the same postoperative care.

For a test power of 80% and the use of an independent t-test for the primary objective and x2 test for the secondary objective with a statistical significance of 0.05, it is necessary to include 42 patients, 21 subjects per group. The test for power calculation is G Power Version 3.1.9.6)(33). And the results will be processed with IBM SPSS statistics v27.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Centre Zagreb
        • Contact:
        • Principal Investigator:
          • Ivan Šitum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients older than 18 years
  • ASA status 1-3,
  • Patients who have an indication for an intraoral surgical procedure longer than 30 minutes.
  • patients who agreed to the research and signed the consent

Exclusion Criteria:

  • ASA status higher than 3,
  • the need for postoperative care in the ICU,
  • surgery lasting more than 2 hours,
  • known allergies to drugs used in the trial,
  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVA group

The study involves patients in an operating room undergoing standard procedures. The induction procedure for anesthesia is the same for both groups, using sufentanil, propofol, and cisatracurium.

In the TIVA group, anesthesia is maintained with continuous propofol infusion and intermittent cisatracurium doses, guided by neuromuscular and electroencephalogram monitoring. At the end of surgery, neuromuscular block is reversed, and extubation occurs when the train-of-four (TOF) index is over 90%.

Muscle strength and bite force are measured at different intervals before and after anesthesia, using specific instruments. Additionally, patients fill out the Quality of recovery-40 (Qor-40) questionnaire at various time points to assess the quality of recovery after surgery and anesthesia.
Drug: Propofol
The experimental group will not receive volatile anesthetic, instead, they will receive propofol infusion
Other Names:
  • TIVA
Active Comparator: Volatile group
In the volatile group, anesthesia is maintained with inhaled sevoflurane and intermittent cisatracurium doses. Cisatracurium is repeated based on TOF ratio, and anesthesia depth is controlled by BIS, maintaining values between 25 and 50. Drug doses are adjusted according to TOF and BIS values.
Drug: Sevoflurane
The control group will not receive TIVA, instead, they will receive sevoflurane via inhalation
Other Names:
  • general volatile anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Quality of recovery from anesthesia" QoR-40 questionnaire
Time Frame: 1 hour, 24 hour, 30 day
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). The total score and subscales of the QoR-40 are measured using a five-point Likert scale (for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed) and individual scores are then added together, with the minimum score being 40 points and the maximum score being 200 points. The QoR-40 was specifically designed to measure a patient's health status after surgery and anesthesia, and its completion time generally ranges from three to 10 min. The Japanese version of the QoR-40 was also validated according to standard methods of cultural adaptation and psychometric analysis in 2011.
1 hour, 24 hour, 30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bite strength and hand grip strength
Time Frame: after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking
Hand-grip muscle strength and bite strength will be measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
after waking in OR up to 10 min, 1 hour after waking, 24 hour after waking
Postoperative nausea and vomiting
Time Frame: 24 hours
determine the difference in the frequency of postoperative nausea and vomiting
24 hours
Postoperative shivering
Time Frame: 2 hour
determine the difference in the frequency of postoperative shivering
2 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Centre Zagreb

Investigators

  • Principal Investigator: Ivan Šitum, MD, UHC Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • situm1phd

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If there is a need and desire on the part of other researchers, data on patients without personal data can be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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