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rrrVrrr^^^^^^����Effect of tramadol on fentanyl induced cough: A double-blind, randomized, controlled study
Abstracts

Background: Tramadol has NMDA antagonist effect and reported to have antitussive effect. The aim of this study to assess the effect of preoperative iv tramadol compared to placebo on the incidence and severity of fentanyl induced cough.
Method: In a prospective, randomized, double-blind study, 100 patients ASA I, age 18-50 years old, scheduled for elective laparoscopic surgeries under general anesthesia. Patients were randomly allocated to one of two groups: Tramadol group received i.v. tramadol 1mg. kg-1 in 100 ml saline and control group received 100 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET ml saline over 30 minutes prior to surgery. The incidence and severity of cough was assessed following injection of fentanyl 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET �g/kg.
Results: The incidence of FIC was significantly less in tramadol treated group being [10 (20%)], compared to control group being [19 (38%)] (p<0.05). Regarding the grade of FIC; 7 out of 10 in tramadol group and 12 out of 19 in control group showed mild form, 3 out of 10 in tramadol group and 4 out of 19 in control group showed moderat form and 3 out of 19 in control group with no patients in tramadol group showed sever form. 
Conclusion: Tramadol 1 mg.kg-1 iv infusion 30 minutes before the operation reduced the incidence and severity of fentanyl induced cough compared to placebo.
Key words: Tramadol; Fentanyl; Cough

Introduction

Fentanyl is a commonly used drug during induction of general anesthesia but the associated fentanyl induced cough (FIC) that may rang from simple to sudden explosive cough is uncomfortable to the patients and may be harmful as it increases the intracranial and intraocular pressures (1). The incidence of FIC ranges from 18% - 65% and its mechanism is unclear (2).

Many techniques have been used to reduce the incidence and severity of FIC including huffing manoeuvre (3), dilution or slow injection of fentanyl (2). Several drugs also have been used including selective B2 agonist, beclomethasone or sodium chromoglycate (4), lidocaine and ephedrine (1), clonidine (5), dexamethasone (6), N-methyl-d-aspartate (NMDA) antagonists (ketamine and dexmethorphane) (7, 8).

Tramadol hydrochloride is a synthetic analogue of codeine, it is a � opioid receptors agonist, it inhibites reuptake of serotonin and noradrenaline and it is a NMDA receptor antagonist (9).
     
It was postulated that tramadol as a NMDA receptor antagonist and has antitussive effect as reported by Lin and his colleagues (10) may be useful in reducing the incidence and severity of FIC. Therefore this study was conducted in a randomized, double-blind, controlled manner to assess the effect of preoperative iv tramadol compared to placebo on the incidence and severity of FIC

Methods

After approval of the local ethical committee, an informed written consent obtained from 100 patients American Society of Anesthesiology(ASA) physical status I, age 18-50 years old, planned for elective laparoscopic surgeries (cholecystectomy, ovarian cystectomy, varicocelectomy) under general anesthesia in Dar Alshifa hospital (State of Kuwait) from April 2012 to November 2012.
Patients were excluded from the study if they were smokers or having history of bronchial asthma, chronic obstructive pulmonary disease, recent respiratory tract infection, or treated with bronchodilator, steroid, or angiotensin converting enzyme inhibitors or allergic to tramadol. 


Sedative premedication drugs were not given to the patients. Patients were randomly allocated into two equally divided groups (50 patients each) by using the closed envelop technique. In order to maintain the blind nature of the study, the studied drugs were given by the ward nurse according to the instructions written in a sealed envelope. 

� Tramadol group: in which tramadol hydrochloride (Tramal,   HYPERLINK "http://en.wikipedia.org/wiki/Gr%C3%BCnenthal" \o "Gr�nenthal" Gr�nenthal GmbH)� 1 mg.kg-1 in 100 ml saline iv infusion was given over 30 minutes before the operation using the same dose used by Lin et al (10).

�Saline group (Control group): in which 100 ml of saline INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET  iv infusion was given over 30 minutes before the operation.

Once the patients arrived to the operation room, the monitors including electrocardiogram, pulse oximetry, and noninvasive blood pressure were attached.
Induction of general anesthesia was started with fentanyl 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET �g/kg as a first drug over a period of 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET seconds and the patients were observed by an anesthesia technician who was blinded for the patient group for 1 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET minute for the incidence of cough (The number of patients developed cough), the severity of cough using the scale used in the study of He et al (11) depend on the number of coughs (mild = 1 2; moderate = 3 4; and severe = e"5). Peripheral O2 saturation (SpO2), heart rate (HR), and mean arterial pressure (MAP) were recorded before fentanyl injection and 1 minute after injection, (O2 desaturation was treated by O2 face mask, bradycardia was treated by atropine 0.4 mg.kg-1, and hypotension was treated by rapid i.v. crystalloid).  The induction was continued by propofol 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET mg/kg and cisatracurium 0.15 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET mg/kg to facilitate orotracheal intubation. Anesthesia was maintained with sevoflurane 1% in O2/N2O (50%/50%). At the end of surgery, sevoflurane was discontinued, the residual muscle relaxant was reversed and the patients were shifted to the recovery room. 

Statistical analysis
The sample size of 50 patients in each group was calculated using the programme of Biostatics version 3.01 based on the result of the previous studies that found that the incidence of FIC was 40% and assuming that tramadol will decrease the incidence of FIC by 50% with the��-error level was fixed at 0.05 and the power was set at 80%.
Data were presented as means (SD) or number (percentage). Numerical data were analyzed by using Student s unpaired t-test. Nonparametric data were analyzed by using the Mann Whitney U-test. A value of P < 0.05 was considered significant. All statistical analysis was performed using Microsoft office Excel.


Results:
Hundred patients were enrolled into the study (50 in each group) including 59 males and 41 females. There were no significant differences between the two groups regarding age, sex, weight, and operation time (table 1).
Incidence of FIC was significantly less in tramadol treated group being [10 (20%)], compared to saline group being [19 (38%)] (p<0.05). Regarding the grade of FIC; 7 out of 10 in tramadol group and 12 out of 19 in saline group showed mild form, 3 out of 10 in tramadol group and 4 out of 19 in saline group showed moderat form and 3 out of 19 in saline group with no patients in tramadol group showed sever form. (table 2)
There were no significant differences in hemodynamic changes (HR & MAP) and peripheral O2 saturation between the two groups at the times of recording. (table 3)


Discussion:

Although opioid drugs have cough depressant effect, i.v. fentanyl paradoxically induces cough. (12)
Many theories have been attributed to explain FIC; the first possible theory may be that fentanyl stimulates C- fiber receptors present in the smooth muscles of the trachea, bronchi, and alveolar wall causing constriction with deformation of bronchial mucosa and stimulation of irritant receptors triggering the cough reflex as selective B2 agonist (Salbutamol) or NMDA antagonists (ketamine) were found to be effective in reducing the incidence of FIC (4, 7). The second possible theory may be that fentanyl induced muscle rigidity as �2 agonist (clonidine) reduced the incidence of FIC through reversal of muscle rigidity (5). 

This study demonstrated that premedication with i.v. tramadol 1 mg.kg-1 reduced the incidence of FIC from 38% in the saline group to 20% when fentanyl was given in a dose of 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET �g/kg as a first drug during induction of anesthesia.

To my knowledge, there were no reports about the effect of tramadol on FIC, also the effective dose of tramadol, so I used the dose of 1 mg/kg as that used in the study of Lin et al., (10)  

Many physical methods and drugs have been used to decrease the incidence of FIC but showing controversial results. Coinciding with the results in this study, ketamine 0.15 mg/kg was given one minute before fentanyl injection decreased the incidence of FIC from 21.6% to 7.2% (7), premedication with oral dextromethorphane 40 mg one hour before induction reduced the incidence of FIC from 59.8% to 3.9% (8),  huffing maneuver (forced expiration against open glottis) before induction reduced the incidence of cough response to fentanyl but this maneuver cannot be used in premedicated patients with midazolam, dilution of fentanyl 10 �g /ml with a prolonged injection time reduced FIC (2), premedication with intravenous clonidine 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET �g/kg decreased FIC from 38.7% to 17.3% with mild reduction in heart rate and blood pressure (5), 	intravenous dexmeditomedine 0.5 �g/kg or 1 �g/kg effectively reduced the incidence of FIC (12), also intravenous ephedrine 5 mg and lidocaine 2mg/kg before fentanyl  decreased the incidence of cough response to fentanyl but lidocaine potentiates cardiovascular depressant effect of the induction agents and  ephedrine  increases heart rate and blood pressure (1).  
On the contrary, propofol 0.6 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET mg/kg before fentanyl failed to decrease the incidence of FIC (1). 

From the previously mentioned possible mechanisms of FIC and the drugs tried to reduce it, the results of this study can be explained by the antitussive effect of tramadol as reported by Lin et al (10) as tramadol has � opioid receptors agonist effect which is involved in the opioid antitussive effect (13 ), also tramadol has NMDA receptor antagonist effect. 

This study showed no hemodynamic changes or oxygen desaturation with i.v. tramadol premedication. This is coinciding with the result of the study of Grossi et al., (14).

This study conclude that tramadol 1 mg.kg-1 iv infusion 30 minutes before the operation reduced the incidence and severity of cough after fentanyl injection 2 INCLUDEPICTURE "http://www.egyptja.org/webfiles/images/transparent.gif" \* MERGEFORMATINET �g/kg compared to placebo.
 
References

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Yu H, Yang XY, Zhang X, Li Q, Zhu T, Wang Y, � HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Liu%20B%5BAuthor%5D&cauthor=true&cauthor_uid=17697219" Liu B. The effect of dilution and prolonged injection time on fentanyl induced coughing.�Anesthesia.�2007; 62: 919�22.
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