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Table of Content - Volume 20 Issue 3 - October 2021
Drug utilisation study of pre-anaesthetic medications in patients undergoing exploratory laparotomy: A cross sectional study
Sunita Pandita1, Seema Gupta2, Rajesh kumar3*
1PG StudenT, 2Professor and HOD, 3Associate professor, Department of Pharmacology, Govt. Medical College Bakshi Nagar, Jammu, INDIA. Email: sunitapandita@gmail.com, vk39@yahoo.com, drrajeshpharma@gmail.com
Abstract Background: Pre-anaesthetic medication is essential to give relief to the patient of pre-operative and post-operative pain and also to reduce secretions and relieve the patient of anxiety. Moreover it is used for synergetic effect with general anaesthetics to decrease their adverse effects. Drug utilization review is an ongoing systemic process designed to maintain the appropriate and effective use of medication. Drug utilization studies are useful for ensuring regular availability of routinely required medicines, especially in large multi-speciality clinical setups. Such studies are also important for ensuring rational use of medicines and to understand drug interaction and reduce adverse effects. There are limited drug utilization studies showing a pattern of Pre-anesthetic medication in Indian settings. Aims and Objective: To evaluate the pattern of pre-anesthetic medication in patients undergoing exploratory laparotomy. Material and methods: In this cross sectional observational study, we collected complete profile of patients in a pre-designed proforma, who underwent exploratory laparotomy under general anesthesia and studied the pattern of pre-anaesthetic medication. Results: A total of 124 patients, with mean age of 38.44± 17.36 years were included in the study. The study population was dominated by male patients (2.26:1). In our study, perforation peritonitis was the most common indication (37.90%) for exploratory laparotomy, followed by intestinal obstruction (22.58%). Ondansetron and tramadol were used in all the patients. Hydrocortisone was administered in 2 patients whereas pantoprazole and glycopyrrolate were given in one patient each. All the medicines were administered by intravenous route. Conclusion: Ondansetron and tramadol were the main pre-anaesthetic medications in the patients undergoing exploratory laparotomy. Glycopyrrolate was the only anticholinergic agent used in one patient. Keywords: Drug utilisation, exploratory laparotomy, pre-anaesthetic medications.
INTRODUCTION Pre-anaesthetic medication is a term applied to the administration of certain drugs prior to general anaesthetic agent so as to make anaesthetic agent safer for the patient. Moreover it gives relief of pre-operative and post-operative pain apart from decrease in the salivary and bronchial secretions and hence prevent reflex laryngospasm. Drug utilization review is an ongoing systemic process designed to maintain the appropriate and effective use of medication. Drug utilization has been defined as the marketing, distribution, prescription and use of drugs in a society especially in large multispeciality clinical setups with emphasis on the resulting medical and social consequences.1 Such studies are also important for ensuring rational use of medicines, understanding drug interactions and reducing the risk of adverse drug events. Pre-anaesthetic medications are administered to prevent anxiety, pain and postoperative complications in patients undergoing surgery under general anaesthesia. Pre-anaesthetic medications are also useful to facilitate the operative procedures.2Various drugs like benzodiazepines, anticholinergic agents, pentazocine, opioids, 5-HT3 antagonists and ranitidine are used as pre-anesthetic medications before surgery. The pattern of pre-anaesthetic medication may differ based on the anaesthetic agent used, profile of the patient, hospital setup and type of surgical procedure. Since the literature review on pre-anaesthetic medication yielded a very scanty data, so we planned to carry out a study to evaluate the use of pre-anesthetic medication in patients undergoing exploratory laparotomy. Aims and objectives: To study the pattern of pre-anaesthetic medications in patients undergoing exploratory laparotomy.
MATERIALS AND METHOD After obtaining approval from the institutional ethics committee[IEC/GMC/2020/91 dated: 12/6/2020], a cross-sectional observational study was conducted in patients of both sexes and of all age groups receiving pre-anesthetic medication for surgical procedures in routine or emergency conditions in a tertiary care teaching hospital in Jammu, North India, for six months. The complete profile of the patients was collected in a pre-designed proforma which included patient’s demographic details, provisional diagnosis, diagnostic methods, co-morbidities, previous history of any medication and indications for exploratory laparotomy. The drugs used during Pre-anaesthetic medications were noted down. The mean number of drugs prescribed in pre-anesthetic medications, percentage of drugs prescribed by generic name and from essential drug list were analysed using the WHO (world health organisation) core drug prescribing indicators (3). Statistical analysis: Categorical variables were presented as number and percentages whereas continuous variables were described as mean and standard deviation.
RESULTS A total 124 patients of both the genders were enrolled in the study. The age of patients ranged from 2.5 years to 85 years. The mean age ± SD of the patient was 38.44 ±17.36 years. Males outnumbered females in the ratio of 2.26:1. Females were comparatively younger than males (Table 1). The demographic data revealed the influence of gender and age in the indications for surgery. The morbidity pattern has been depicted in Table 2. Perforation peritonitis was the most (37.90%) common indication for exploratory laparotomy followed by intestinal obstruction (22.58%), appendicular perforation (9.68%) and penetrating injury abdomen (8.87%). Ondansetron and Tramadol in different doses were given in all the patients in pre-anaesthetic medication in pre-anaesthetic medication. The commonly used doses of ondansetron were 4mg (93.54%), 2mg (4.03%), 8mg (1.61%) and 1mg (0.80%). Whereas the tramadol was given in the dose of 70 mg (34.67%), 60 mg(27.41%), 50 mg (14.51%), 80 mg (9.67%), 100 mg (8.08%), 40 mg (3.22%), 20 mg (1.61%) and 10 mg (0.80%). Apart from these, hydrocortisone was administered in 2 patients whereas pantoprazole and glycopyrrolate were given in one patient each. All the medicines were administered by intravenous route (Table 3). The drugs prescribed from essential drug list were 80% and none of the drug was prescribed by generic name.
Table 1: Baseline characteristics of the patients Parameters Results (n=124)
Figure 1: Gender wise distribution of study population Figure 2
Table 2: Indications for the exploratory laprotomy
Table 3: Drugs used in pre-anaesthetic medication.
DISCUSSION General anaesthetics are a major and important drug category in use in which the practice has to be taken into consideration of several aspects of convenience and safety. Use of pre-anaesthetic medicines for facilitation of surgery and decrease the risk of surgery related complications is a common practice worldwide. There may be geographical variations in the pattern of pre-anaesthetic medicine usage. Drug utilization studies help us to understand the appropriate drug and dosage according to patients need, type and duration of surgeries. Drug utilization studies are also helpful for scientific as well as administrative purposes in large hospital setting especially in tertiary care centers. Significant insights into the use of medicines, indications, side effects, and drug interactions can be obtained from such studies.1,5In our study, the study population was predominantly adult patients with mean ± SD age of 38.44 ± 17.36 years. Moreover, male outnumbered females in the ratio of 2.26:1. This gender difference may be due to smoking, alcohol intake and diet rich in saturated fats seen commonly in Indian males. The baseline characteristics of the study population are in accordance with the previous study carried out in India4,5 but in sharp contradiction to another study conducted in India (6) where the number of females patients was more than males. In the present study, perforation peritonitis (37.90%) followed by intestinal obstruction (22.58%) were the two most common indications for exploratory laparotomy. These results are in accordance with the some other studies conducted in India.4 Kulkarni et al.5 observed carcinomas/tumor as the leading cause for major surgical procedures. This may be the due to the fact that they have enrolled all patients undergoing major surgical procedures under general anaesthesia. Pre-anesthetic medications are used to reduce gastric acid, volume of gastric secretion, increase gastric pH, reduce the risk of nausea, vomiting and aspiration of gastric contents during post-operative period.7,8,9 Unwanted side effects of drugs like antihistaminics, anticholinergics, dopamine antagonists, and phenothiazine derivatives, have limited their use in the management of post-operative nausea and vomiting.10 A retrospective Pharmacoepidemiological study reported the use of Midazolam, Glycopylorate, Ondansteron and Fentanyl as a premedication in 92.1% patients6 and observed fentanyl as a opiod of choice because it is short acting and can be used even in patients with deranged liver functions. A Cochrane review determined the antiemetic effect of ondanestrone, dolasetrone, granisetrone, tropisetrone, dexamethasone, droperidole, cyclizine and metoclopramide in 103237 patients and observed that all these drugs effectively prevented nausea or vomiting after surgery.11 However it did not find evidence that one drug was better than another. Age, sex, type of surgery or premedication timing did not change the drug effects, and the effects become additive when two or more drugs were given together. These agents are significantly effective in the prevention of post-operative nausea and vomiting. Ondansetron, the first agent introduced in this class, is devoid of any significant effect on other receptors (e.g., dopamine, histamine, or sympathetic/parasympathetic receptors) apart from 5-HT3.10 One meta-analysis has showed comparable efficacy of ondansetron, granisetron, tropisetron, and dolasetron in the prophylaxis of PONV alone.12 Such discrepancy can partly be attributed to the different affinity for 5HT3 receptors and different half-life varying from 3-7 hours. In their study Clark et al.13 observed that ranitidine given is more effective than proton-pump inhibitors in reducing volume of gastric secretion and increasing gastric pH. Another prospective, randomized, double-blind study showed that intravenous prophylactic ranitidine and metoclopramide is useful to reduce the volume of gastric content and increase gastric pH.14 In our study, all the patients received injection intravenous ondansetron injection. Only one patient was administered intravenous pantoprazole (PPI) injection. In the present study, injection tramadol was given to all (100%) patients preoperatively to control post operative pain. Wang et al.15 demonstrated that intravenous pentazocin administrated 10 min before surgery provides a reduction in intraoprerative pain, hemodynamic change, postoperative pain intensity, and tramadol consumption during major surgical procedures under general anesthesia. Administering an analgesic medication before the start of the surgical stimuli can decrease or block the development central pain sensitization and then result in less postoperative pain.16 Patil and Kulkarni4 observed common use of pentazocine as a pre-anesthetic medication for exploratory laparotomy. As pre-surgical period is often associated with stress, fear, and anxiety. Benzodiazepines are commonly used as pre-anesthetic medications to reduce anxiety. In a retrospective study from India, alprazolam was the most commonly used anti-anxiety benzodiazepine.17 In an old survey, anticholinergic premedication use was reported in 36% and 56% of adults and children, respectively. The results showed atropine and hyoscine to be the most commonly used anticholinergic drugs.18 In our study, 1 (0.80%) patients received glycopyrrolate.
CONCLUSION It is apparent from the observation that the choices of anaesthesia as well as outcome of procedures were predictable from theoretical understanding. The choices were therefore rational. The two major pre-anesthetic medications used in patients undergoing exploratory laparotomy include ondansetron and tramadol. Glycopyrolate was the only anticholinergic agent used in one patient.
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