RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

SYNOPSIS

Subject for Dissertation

TITLE OF THE TOPIC

RECOVERY PROFILE WITH FENTANYL ALONE, FENTANYL WITH PROPOFOL AND FENTANYL WITH MIDAZOLAM FOR PROCEDURAL SEDATION AND ANALGESIA

Guide:

Dr. K. Umesh

Professor and Head

Department of Oral and Maxillofacial Surgery

Submitted by:

Dr. Modi Rifaz Riyaz

PG in Department of Oral and Maxillofacial Surgery

AL-AMEEN DENTAL COLLEGE BIJAPUR

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARANATAKA

ANNEXURE – II

Proforma for Registration of Subject for Dissertation

| | | | |

|1. |NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS) |: |Dr. MODI RIFAZ RIYAZ |

| | | |DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, |

| | | |AL-AMEEN DENTAL COLLEGE |

| | | |BIJAPUR- 586108 |

| | | | |

|2. |NAME OF THE INSTITUTION |: |AL-AMEEN DENTAL COLLEGE |

| | | |BIJAPUR,KARNATAKA 586108 |

| | | | |

|3. |COURSE OF THE STUDY AND SUBJECT |: |MASTER OF DENTAL SURGERY |

| | | |(ORAL AND MAXILLOFACIAL SURGERY) |

| | | | |

|4. |DATE OF ADMISSION TO COURSE |: |30th May 2013 |

| | | | |

|5. |TITLE OF THE TOPIC |: |RECOVERY PROFILE WITH FENTANYL ALONE, FENTANYL WITH PROPOFOL AND |

| | | |FENTANYL WITH MIDAZOLAM FOR PROCEDURAL SEDATION AND ANALGESIA |

|6 |BRIEF RESUME OF INTENDED WORK |

|6.1 |NEED FOR THE STUDY: |

| |The management of the fear and apprehension on the part of the patient undergoing surgery has been an integral part of |

| |patient management. |

| |Administration of intravenous medication is a popular technique to sedate patients before outpatient dental treatment and |

| |oral and maxillofacial surgery.3 |

| |Objective of the use of opioid and non-opioid during MAC [Monitored Anesthesia Care] is to decrease the pain with injection|

| |of LA as well as the discomfort related to non-incisional factors[ e.g. back pain by lying on hard OT table or pressure and|

| |traction on deep tissues that are not rendered insensitive by local anesthetic solution ] |

| |Intravenous sedation or general anesthesia is indicated for relief of anxiety associated with outpatient surgical |

| |procedures. Conscious sedation is a method of depression of the central nervous system that allows the operator to perform|

| |a surgical procedure during which the patient retains protective reflexes.2 |

| |The goals of sedation in dentistry are to relieve anxiety, elevate the pain threshold, render a patient compliant, and |

| |induce amnesia. In particular, benzodiazepines in combination with opioids have frequently been used to relieve |

| |apprehension and elevate pain thresholds.3 |

| | |

| |Dionne and Miller, Bullard, and Patrissi have suggested that use of an opioid decreases the dose of benzodiazepine needed |

| |to sedate the patient, which may result in less relief of anxiety and shorter duration of amnesia.3 |

| |A study to compare recovery of patients sedated with either midazolam or diazepam alone or in combination with fentanyl |

| |using the digit symbol substitution [DSST] and Trieger test.1 |

| |The aim of the study is to describe and compare the results of a double-blind, controlled clinical trial in which the |

| |safety, efficacy and the recovery profile of several different combinations of sedative agents, including the narcotic |

| |i.e. fentanyl alone and its combination with midazolam and propofol. |

|6.2 |REVIEW OF LITERATURE |

|1. |Ochs MW, Tucker MR, White RP, Anderson J A. in the year 1986 conducted a study to compare recovery of patients sedated with |

| |either midazolam or diazepam alone or in combination with fentanyl using the digit symbol substitution [DSST] and Trieger |

| |test .Patients were randomly divided into treatment groups and recovery tests were administered to the patients prior to |

| |sedation and at 60, 120, and 180 minutes after achieving a standardized sedative endpoint. Patients who received midazolam |

| |alone had significantly fewer numbers of correct responses on the DSST than patients who received midazolam plus fentanyl or |

| |diazepam with or without fentanyl. They concluded that in addition of fentanyl to the sedation regimen allows reduction in |

| |the midazolam dose resulting in a recovery time comparable to that of diazepam. |

|2. |Parworth LP. et al, in the year 1998 conducted a study on 57 patients undergoing removal of third molars under intravenous |

| |sedation to measure the safety and efficacy of propofol combined with fentanyl as sedative agent during third molar |

| |outpatient surgery. They found that propofol appears to be a safe and efficacious drug for use during outpatient oral |

| |surgical procedures. |

|3. | Milgrom P. et al, in the year 1993 conducted a study examined midazolam and midazolam plus fentanyl in a placebo-controlled,|

| |double-blind clinical trail. It tested the hypothesis that combined drug therapy results in significantly poorer safety but |

| |no difference in efficacy compared to the single drug approach. Subjects in the combination group were more than four times |

| |as likely to have excellent versus good, fair, or poor sedation at a given level of intra-operative pain, and behavioral |

| |[movement and verbalization ] but not cognitive measures of anxiety were attenuated. |

|4. |Zuhal Kucukyavuz and Mine Cambazoglu, in the year 2004 have conducted a study on thirty patients to assess the effects of |

| |low-dose midazolam with propofol and propofol alone for PCS during minor oral surgery on oxygen saturation, amnesia, |

| |recovery, level of sedation, condition of the patient and satisfaction. They found that low dose midazolam with propofol |

| |improves the acceptability and comfort for patients and made the operation easier, which makes it preferable to propofol |

| |alone. |

|5. |Ramirez-Ruiz M, Smith I, White PF. in the year 1995 have conducted study to evaluate the comparative efficacy and side |

| |effect profile of ketorolac 60mg, dezocine 6mg, Fentanyl 100ug when used as analgesic supplements to a propofol infusion |

| |during monitored anesthesia care (MAC) and concluded to compared with ketorolac 60mg, Fentanyl 100ug and dezocine 6 mg |

| |produced a greater decrease in the propofol sedation requirement during MAC .however, the use of ketorolac in combination |

| |with propofol of MAC was associated with an improved recovery profile. |

|6.3 |OBJECTIVES OF THE STUDY |

| |To evaluate the level of sedation during intra-operative period. |

| |To evaluate the recovery profile at the time of discharge. |

| |To evaluate discomfort during recovery period. |

| |To evaluate acceptance by the patient and surgeon. |

| |To evaluate of cardiovascular status. |

| |To evaluate post-operative amnesia. |

|7. |MATERIALS AND METHODS |

|7.1 |SOURCE OF DATA: |

| |Patients reporting to Department of Oral & Maxillofacial surgery, Al-Ameen Dental College and Hospital, 150 patients who|

| |need to undergo minor oral and maxillofacial surgical procedures are selected for the study, if they fulfill the |

| |selection criteria. |

| |Patients are selected randomly. |

| |Patients are divided into 3 groups namely Group A, Group B & Group C consisting of 50 patients each, who will be |

| |administered with fentanyl, fentanyl with midazolam and fentanyl with propofol randomly. |

|7.2 |METHOD OF COLLECTION OF DATA: (INCLUDING SAMPLING PROCEDURE IF ANY) |

| | |

| |Inclusion criteria: |

| |In this study 150 patients are selected who require a minor oral and Maxillofacial Surgical procedure. |

| |Patients are selected randomly. |

| |Patients aged between 14 years to 65 years. |

| |Patients who fulfill ASA (American Society of Anesthesiologists) Grade I and II. |

| | |

| |Exclusion criteria: |

| |Patients who fulfill ASA grade III and above are excluded from the study. |

| |Patients who are on any type of psychoactive medication, sedatives and hypnotics. |

| |Patients having positive history of any neuromuscular, musculoskeletal cardio-respiratory disorders, hepatocellular and |

| |renal diseases. |

| |Patients with known hypersensitivity to opioids and benzodiazepines. |

| |Patients who weigh more than 130 kg. |

| |Patients with acute intoxication with drugs and alcohol. |

| |METHODOLOGY |

| |Patients are divided into 3 groups namely Group A, Group B & Group C consisting of 50 patients each, who will be |

| |administered with fentanyl, fentanyl with midazolam and fentanyl with propofol randomly. |

| |Patients will be given a IV injection of 0.5 µg/kg fentanyl(1 µg/kg fentanyl when administered alone), IV injection of|

| |0.05 mg/kg of midazolam, IV injection of propofol 0.7 mg/kg mentioned combination. |

| |After 5th minute of injection of the above mentioned combination, the local anesthetic is injected. |

| |After adequate local anesthesia, the operation is begun. |

| |Throughout the study blood pressure, pulse rate, and peripheral oxygen saturation are monitored non-invasively. |

| |The level of sedation is recorded at the 5th minute of sedation i.e. the time of injection of Local anesthetic, at the |

| |end of surgery, one hour postoperatively and at the time of discharge using a Modified Ramsey’s Sedation Scale. |

| | |

| | |

| | |

| | |

| | |

| | |

| |Sedation levels are monitored by |

| |MODIFIED RAMSEY’S SEDATION SCALE |

| |Anxious, Agitated ,Restless. |

| |Co-operative, Oriented, Tranquil. |

| |Responds to commands only. |

| |Responds to gently, shaking. |

| |Responds to noxious stimuli. |

| |No response to noxious stimuli. |

| | |

| |To evaluate the patient’s opinion about sedation, a modified visual analogue scale (VAS) is used where 1 represents |

| |totally calm and relaxed, and 10 represents worst fear imaginable. |

| |The condition of the patient during surgery is evaluated by the surgeon according to the following criteria: |

| |Excellent= patient calm and cooperative |

| |Good= patient a little nervous and little resistant to procedure. |

| |Bad= patient is extremely nervous and very resistant towards the procedure. |

| |This evaluation is repeated during the injection of local anesthetic and the operation. |

| | |

| | |

| |Amnesia is evaluated at 60th minute, at the time discharge and 1 week postoperatively by asking the patient whether they|

| |remember: |

| |The object that was shown half way intra-operatively. |

| |Injection of local anesthetic |

| |The operation |

| |Suturing |

| |Journey to the in-patient clinic. |

| |Specific tests will be used for Recovery Scoring(like bead test, Trieger test, DSST) |

| |Before sedation, all patients complete the ball bearing test to evaluate the psychomotor function. They are asked to |

| |carry 40 beads with a tissue forceps from one cup and to another within 40 seconds. The number of beads carried is |

| |recorded as the score. This test is repeated at 15th, 30th, 45th, and 60 minutes postoperatively. |

| |Patients will be discharged as soon as their general condition is near normal as possible. |

| |All side affects during sedation and post operative period are recorded. |

| |One week after the operation, the patient is asked about the unexpected affects of this method as well as their opinion |

| |about it. |

| |All the data will be collected on a Proforma and tabulated. |

| |The results will be subjected to relevant statistical analysis, and the conclusions will be drawn. |

|7.3 |DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN OR ANIMALS? IF SO |

| |DESCRIBE BRIEFLY. |

| |Yes, |

| |After Obtaining Written Consent, Necessary Investigations Include : |

| |Routine blood and urine investigation. |

|7.4 |HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? |

| |Yes |

| |The ethical committee clearance has been obtained. |

|8. |LIST OF REFRENCES |

| |Ochs MW et al. Recovery Following Sedation with Midazolam or Diazepam Alone or in Combination with Fentanyl for |

| |Outpatient Surgery Anesth Prog 1986,230-234 |

| |Parworth LP.et al, Propofol and Fentanyl compared with Midazolam and Fentanyl during third molar surgery. J Oral |

| |Maxillofacial Surg 1998; 56: 447-453. |

| |Milgrom P. The safety and Efficacy of Outpatient Midazolam Intravenous Sedation for Oral Surgery with and without |

| |Fentanyl .Anesth Prog 1993; 40:57-62 |

| |Zuhal Küçükyavuz, Mine Cambazoglu. Effects of low-dose midazolam with propofol in patient-controlled sedation (PCS) |

| |for apicectomy. Br J Oral Maxillofac Surg 2004;42:215-220. |

| |Ramirez-Ruiz M, Smith I, White PF. Use of Analgesices During Propofol Sedation: A comparison of Ketorolac, Dezocine,|

| |and Fentanyl. |

| | |

|9. |Signature of the candidate | | |

|10. |Remarks of the Guide | | |

|11. |Name and Designation of | | |

| |11.1 Guide | |Dr. K. Umesh M.D.S |

| | | | |

| | | |Professor and Head |

| | | |Department of Oral and |

| | | |Maxillofacial Surgery |

| | | |Al-Ameen Dental College and Hospital, Bijapur |

| |11.2 Signature | | |

| |11.3 Co-Guide | |Dr. Rajendra Kumar B. M.D |

| | | | |

| | | |Professor and Head |

| | | |Department of Anesthesiology |

| | | |Al-Ameen Dental college and hospital, Bijapur |

| |11.4 Signature | | |

| |11.5 Head of the Department | |Dr. K. Umesh M.D.S |

| | | | |

| | | |Professor and Head |

| | | |Department of Oral and |

| | | |Maxillofacial Surgery |

| | | |Al-Ameen Dental College and Hospital, Bijapur |

| |11.6 Signature | | |

| |12.1 Remarks of the Chairman and Principal | | |

| |12.2 Signature | | |

CONSENT FORM

I have been informed about the procedures of the study. The possible risks too

have been explained to me. I have understood that I have the

right to refuse my consent or withdraw it any time during the study without

adversely affecting my treatment. I have been provided ample time to ask

questions and I have clarified to my satisfaction. I am also aware that

subjecting to this study, I will have to give more time for assessments by the

doctor and these assessments do not interfere with the benefits.

I, ………………………………................................ the undersigned, give my

consent to be a participant of this study.

SIGNATURE OF PATIENT/

THUMB IMPRESSION:

NAME :

ADDRESS AND PHONE NUMBER:

SIGNATURE OF THE DOCTOR

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