A comparison between Fentanyl and Nalbuphine for intubating conditions during awake fiberoptic broncoscopy in oral carcinoma surgeries: A randomized comparative prospective study

A comparison between Fentanyland Nalbuphine for intubating conditions during awake fiberoptic broncoscopy inoral carcinoma surgeries: A randomized comparative prospective study

INTRODUCTION

Oralcancer is the sixth most prevalent cancer worldwide. 1 It is themost prevalent cancer among males in India and is associated with tobacco and gutka use. Even if the humanpapillomavirus has lately been linked to the development of oral cancer, other morewidespread causes in India must not be neglected. Surgery is the first-linetherapy for oral cancer.2 Due to the reduced mouth opening anddecreased interincisor space, airway difficulty is a primary anaesthetic issueduring surgery. Patients with oral cancer who undergo radiation as theirprimary treatment are more likely to experience limited neck motion, as well asrestricted mouth opening.

Fiberoptic and videotechnologies are widely used during laryngoscopy for airway management. Awakefiberoptic intubation (AFOI) is the technique of choice in anticipateddifficult airway situations. However, patients need to be prepared bothpsychologically and pharmacologically for cooperation and avoidance of violentwithdrawal, vomiting or vigorous coughing, gagging, and glottic closure reflexduring intubation.1 Hemodynamic responses like increase in heartrate and blood pressure and desaturation can occur during AFOI, presentingchallenges to the procedure.2 Therefore, it is essential to preparepatient’s airway for obtundation of airway reflexes, providing adequatesedation and anxiolysis without the loss of airway patency with preservation ofadequate ventilation.

 Benzodiazepines, propofol, opioids,dexmedetomidine, etc., are some of the drugs used for this purpose. Propofolhas rapid onset and offset of action with profound amnesia but is associatedwith apnea, hypotension, and pain on injection.3Fentanyl attenuatesthe hemodynamic response and discomfort during passage of the bronchoscopethrough vocal cords. It has a rapid onset with a duration between 30 and 50 minbut may be associated with respiratory depression, nausea, vomiting, anditching during recovery.4

Nalbuphine is an agonist-antagonistopioid. Because of its pharmacological properties, nalbuphine results inanalgesia without respiratory depression, pruritus, and sedation  due to activation of supraspinal and spinalκ-receptor. It has been administered as an analgesic supplement for conscioussedation] or balanced anesthesia and as an analgesic for postoperative andchronic pain.

Mondal S, et al(2015)  conducted a randomizeddouble-blind prospective study  on  60 patients scheduled for electivelaparotomies who were randomly allocated into two groups: Group A receiveddexmedetomidine 1 mcg/kg and Group B received fentanyl 2 mcg/kg over 10 min.Adequacyof intubation condition was evaluated by cough score and post-intubation score.Cough Score (1-4), post-intubation Score (1-3) and RSS (1-6) were significantlyfavorable (P < 0.0001) along with minimum hemodynamic responses tointubation (P < 0.05) and less oxygen desaturation (P <0.0001) in Group A than Group B. Dexmedetomidine is more effective thanfentanyl in producing better intubation conditions, sedation along withhemodynamic stability and less desaturation during AFOI.

Eldemrdash, A  et al (2017) conducted a study to evaluateand compare the efficacy of Dexmedetomidine or Fentanyl for sedation duringAFOI. They conclude that Dexmedetomidine provides better intubating condition,sedation, less respiratory depression and hemodynamic stability than fentanylfor AFOI, without adversely affecting airway.

Sharma et al (2017)  conducted study to compare patients’Observer’s Assessment of Alertness/Sedation scale (OAA/S) as primary outcomeand other variables such as endoscopy, intubation condition, tolerance andhaemodynamic stability among low and standard doses of dexmedetomidine. Group Hhad more favourable OAA/S score than that of Group L, but endoscopy and intubationtime, patient tolerance, vocal cord and limb movement and satisfaction scoredid not differ significantly between the groups. There were no significanthaemodynamic differences between the two groups.

                   Aimand Objectives:

Aim:

·       To compare ease of fiberoptic intubationwith intravenous nalbuphine versus fentanyl in difficult intubation patientsundergoing oral carcinoma surgery

PrimaryObjective

·       To compare intubating conditions among two groups withintubation score (Coughing  and  post intubation score)

Secondary Objective:

·       To compare haemodynamic parameters  among  two groups.

·       To compare sedation (Ramsay sedation score)  among two groups.

    Materialsand Methods:

Study Setting:

The study will beconducted in Department of Anaesthesiology, King George’s Medical University,Lucknow in various operation theatres after getting clearance from the ethicalcommittee, Research Cell, KGMU, Lucknow.

Study Design:

Prospective Randomized study

Study Duration:

18 months

  Sample size calculation

ProposedObjective: To compare intubating conditions among two groups with intubationscore, cough score and Ramsay sedation score.

Weare going to perform a study to compare Fentanyl and Nalbuphine for IntubatingConditions during awake fiberoptic bronchoscopy In oral carcinoma Surgeries. Ina previous study (Akheela and Chandra. Comparative evaluation of Nalbuphine andFentanyl for attenuation of pressor response to laryngoscopy and trachealIntubation in laparoscopic cholecystectomy. Cureus. 2021 May 20;13(5):e15142.doi: 10.7759/cureus.15142.)5 drowsy state wasin 32.22% cases in Nalbuphine group and 13.33% in Fentanyl group. In presentstudy we also expect a similar outcome. The sample size was calculated usingthe following formula suggested by Charan and Biswas (2013)6

n= 2*(Zα/2+Zβ) 2*P*(1-P)/(p1-p2) 2

where, n: Sample size

Zα/2: critical value of z at 95% confidence = 1.96

Zβ:critical value of z at 80% power = 0.84

p1-p2= Difference in proportion of two eventsin two groups=0.19

P=pooled Prevalence = (p1+p2/2)= 0.225

n= 2* (1.96+0.84)  *(0.225)*(0.775) / (0.036) 2 = 75.75

Thusthe calculated sample size is 75. Keeping a provision of data loss @ 2%, theproposed sample size is 77 patients in each group or a total of 154 case

Inclusion Criteria:

·       Patients included in the studyshould meet the following inclusion criteria-

·       Age- 18-70 years of either gender

·       ASA  physical status -I  or II

·       Type of surgery- Oral carcinomasurgery

·       Nature of surgery-Elective

·       MP grade III &IV

·       Type of anaesthesia- GeneralAnaesthesia

·       Patients giving written informedconsent

 â€¢      ExclusionCriteria

·       Patient Refusal

·       MP grade I &II

·       ASA III &IV

·       Allergy to drug

·       Major cardiorespiratory disease

·       Emergency surgeries

·       Difficult mask ventilation

·       Nasal mass

·       Coagulation disorder

·       Hepatic or renal disease

·       Pregnant patients

 METHODOLOGY:

After taking approval from the InstitutionalEthics Committee and InformedConsent, all patients will be randomly allocated to one of the twogroups of 75  patients in each group ,according to a computer-generated random number table. All  patients will be  kept nil per orally for 8–10 h prior to theprocedure. Patients will be premedicated with Tab Alprazolam 0.25 mg nightbefore  surgery.In pre operative room,patency of both the nostrils will be tested and the nostril with better patencywill be identified and xylometazoline nasal drops will be instilled in bothnostrils. An intravenous(iv)line will be secured. Injection emset 4mg and inj.Rantac 50 mg will be administered 15 minutes before surgery. Nebulization willbe done with 4% lignocaine 4 ml (160 mg) over 15 min.Patient will be shifted tooperation theatre (ot) table and all essential monitoring will be attached .Heart rate(HR), systolic blood pressure(SBP), diastolic blood pressure(DBP),mean arterial pressure(MAP), oxygen saturation(SPO2) and end tidalco2(ETC02) will be recorded at baseline, just before intubation, 2 min,3 minafter intubation thereafter every 5 minutes . Just before intubation O2 flowwill be started at 35 lit/min via High-Frequency Nasal Cannula (THRIVE technique**)**  and will be  continueduntil the end of intubation. Two puffs of 10% lignocaine (10 mg/puff) will beused to anesthetize tongue and hypopharynx followed by spray as you go [SAYGO] technique.

Group F :patients will receive fentanyl 2 μg/kg of bodyweight I.V. and Group N : patients will receive nalbuphine 0.2 mg/kg of bodyweight I.V. Drug will be diluted in 10 ml normal saline and administered over aperiod of 10 min in both the groups. Fiberoptic bronchoscope will be prepared by lubrication withlignocaine jelly and an appropriate sized cuffed polyvinyl chlorideendotracheal tube will be loaded over it. At the end of study drug infusion,sedation will be evaluated by Ramsay sedation score (RSS) :- 1-Anxious,agitated, or restless  2-Cooperative,oriented, or tranquil  3-Sedated butresponding to loud noise  4-Asleep, briskglabellar reflex, or response to loud noise 5-Asleep, sluggish glabellar reflex, or response to loud noise, and6-Asleep with no response to painful stimulus.

Once the RSS score ≥3 was achieved,bronchoscopy will be performed through nasal approach from the more patentnostril. Oxygen will be supplemented throughout the procedure through the othernasal cavity via a HFNC. Once the vocal cords will be visualized, aliquots of 2ml (40 mg) 2% lignocaine spray will be administered to facilitate furtheradvancement of bronchoscope till the carina is  visualized.Tracheal tube will be rail-roadedover the fiberscope. The fiberscope will be then withdrawn and the placement ofthe tube will be confirmed with auscultation and ETC02 graph. General anesthesia will be inducedin accordance with the standard protocol and surgery will be allowed toproceed.If propofol is required , the patient will be dropped from study group.Intubating conditions  will be evaluated in terms of cough score (1-no cough, 2-slight cough 3-moderate cough 4-severe cough duringbronchoscopy) and post intubation score (1-2-minimal resistance, 3-severeresistance)The total dose of lignocaine used  during bronchoscopy will be  recorded.

   REFERENCES

1. Mondal S, Ghosh S, Bhattacharya S, Choudhury B,Mallick S, Prasad A. Comparison between dexmedetomidine and fentanyl onintubation conditions during awake fiberoptic bronchoscopy: A randomizeddouble-blind prospective study. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):212-6.doi: 10.4103/0970-9185.155151. PMID: 25948903; PMCID: PMC4411836.

2. Ramkumar V.Preparation of the patient and the airway for awake intubation. IndianJ Anaesth.

3. Vuyk J, SitsenE, Reekers M. Intravenous anaesthetics. In: Miller RD, editor. Miller’sAnaesthesia. 8th ed.

4. Adachi YU,Satomoto M, Higuchi H, Watanabe K. Fentanyl attenuates the hemodynamic responseto endotracheal intubation more than the response to laryngoscopy.

5.mohamed kassimakheela,alka Chandra  Comparae Evaluation of Nalbuphine and Fentanyl forAttenuation of Pressor Response to Laryngoscopy and Tracheal Intubation inLaparoscopic Cholecystectomy.

6. Charan, J. and Biswas. T. (2013)  to Calculate Sample Size for Different                                                              Study Designs in MedicalResearch.