scholarly journals A Randomised Clinical Trial to Compare the Efficacy of Tramadol and Nalbuphine for Treatment of Shivering after Spinal Anaesthesia in Patients Posted for Lower Limb Orthopaedic Surgery

2021 ◽  
Author(s):  
Sara Mary Thomas ◽  
Ananya Pradhan ◽  
Dinesh Chauhan
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Spinal Anaesthesia ◽  
Muscular Activity ◽  
Total Sample ◽  
Randomised Clinical Trial ◽  
Muscle Group ◽  
P Value ◽  
Entire Body ◽  
Grade 3

Introduction: Nalbuphine and tramadol are opioids which have been used to control post-anaesthetic shivering. Aim: To compare the efficacy of nalbuphine and tramadol in the treatment of post-spinal anaesthesia shivering. Materials and Methods: This was a randomised clinical trial conducted on 60 patients of either gender (20-60 years age group) from January 2019 to June 2020, American Society of Anaesthesiologists (ASA) Grade I or II, having post-spinal anaesthesia shivering. The total sample was divided into two groups of 30 patients each. Group T received injection (Inj) tramadol 1 mg/kg intravenously (iv) and Group N received Inj. nalbuphine 0.1 mg/kg iv. Grade of shivering was assessed with a five point scale as Grade 0- no shivering; Grade 1; No visible muscle activity, but one or more of piloerection, peripheral vasoconstriction or peripheral cyanosis Grade 2; Muscular activity in only one muscle group; Grade 3: Moderate muscular activity in more than one muscle group, but not generalised shaking; Grade 4: Violent muscular activity that involves the entire body. The time taken for disappearance of shivering, assessment of improvement of shivering (complete- if grade of shivering becomes 0, partial- if grade of shivering deceased but not zero), recurrence rate and side-effects such as nausea, vomiting, deep sedation were noted. Independent t-test and Chi-square test were used to analyse the data. A p-value <0.05 were considered statistically significant. Results: The time taken for disappearance of shivering was shorter in group N than T (3.20±0.96 minutes and 6.43±0.97 minutes respectively, p=0.001). Significantly better sedation (p-value 0.04) was seen in nalbuphine group as grade 3 sedation were seen in 15 patients of nalbuphine group as compared to none in tramadol group. All the patients in group N had complete improvement of shivering and there was no recurrence, while in group T six patients had partial improvement in shivering and four (13%) had recurrence. Complications such as nausea (three patients) and vomiting (one patient) were seen in Group T while none were seen in Group N. Conclusion: The efficacy of nalbuphine is greater than tramadol in controlling post-spinal anaesthesia shivering, with minimal side-effects.

Plain Articaine or Prilocaine for Spinal Anaesthesia in Day-Case Knee Arthroscopy, a Double-Blinded Randomised Clinical Trial

2008 ◽  
Vol 33 (Sup 1) ◽  
pp. e32
Author(s):  
M. P. Hendriks ◽  
C. J.M. de Weert ◽  
M. A.L. Pluim ◽  
H. P. Hu ◽  
M. M.J. Snoeck ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Anaesthesia ◽  
Knee Arthroscopy ◽  
Randomised Clinical Trial ◽  
Day Case ◽  
Double Blinded

641. Plain Articaine or Prilocaine for Spinal Anaesthesia in Day-Case Knee Arthroscopy, a Double-Blinded Randomised Clinical Trial

2008 ◽  
Vol 33 (Suppl 1) ◽  
pp. e32.1-e32
Author(s):  
M. P. Hendriks ◽  
C. J.M. de Weert ◽  
M. A.L. Pluim ◽  
H. P. Hu ◽  
M. M.J. Snoeck ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Anaesthesia ◽  
Knee Arthroscopy ◽  
Randomised Clinical Trial ◽  
Day Case ◽  
Double Blinded

Reconsenting patients with cancer on clinical trials: Does added risk influence continued participation?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15610-e15610
Author(s):  
A. Elegbede ◽  
A. Andrei ◽  
A. Andrei ◽  
K. D. Holen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Side Effects ◽  
Adverse Events ◽  
Study Participant ◽  
P Value ◽  
Study Participation ◽  
Grade 5 ◽  
Study Results

e15610 Background: The general policy endorsed by multiple professional societies and cooperative groups regarding patients on cancer clinical trials states that subjects should be informed of new adverse events or significant developments during study participation and re-consented to continue on study. However, no information is known as to the effect of re-consenting on a patients’ decision to continue study participation. Our research question addresses how the severity of reported risk to other study participants will impact the subjects’ decision to continue participation in a clinical trial. Methods: We surveyed 34 patients with gastrointestinal (GI) tumors all of whom were currently enrolled in a clinical trial. The survey portrayed hypothetical adverse reactions affecting another study participant ranging from Grade 1 to Grade 5 according to the National Cancer Institutes Common Terminology Criteria for Adverse Effects v. 3.0. The survey asked about subjects’ opinions of the theoretical adverse event categorized as “would not be concerned,” “would be concerned, but would continue the study,” and “would discontinue the study.” Results: Patients willingness to continue the study was highest at Grade 1 with 97% of all participants. However, willingness to continue participation progressively declined as the severity of adverse events increased such that only 44% of participants would continue participation with a reported Grade 5 adverse event. Conclusions: Among surveyed GI cancer patients, willingness to continue participation in a clinical trial declined significantly as the severity of adverse events increased from Grade 1 to Grade 3 - 5 (p-value < 0.001. This could be due to multiple factors, including the terminal nature of the patients’ cancer, the side effects of study therapy and the patients’ response to study treatment. This data could produce a reasonable adverse event grade cut-off for re-consenting patients regarding new side effects. No significant financial relationships to disclose.

scholarly journals A prospective observational study involving three fixed infusion regimens of phenylephrine for hemodynamic support during spinal anaesthesia for caesarian delivery

2019 ◽  
Vol 8 (6) ◽  
pp. 2293
Author(s):  
Aymen Masood ◽  
Ajaiz Rasool ◽  
Aabid Hussain Mir ◽  
Waqurl Neesa ◽  
Ayaz Farooqi
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Placebo Group ◽  
Side Effects ◽  
Spinal Anaesthesia ◽  
Statistical Difference ◽  
P Value ◽  
Significant Statistical Difference ◽  
Umbilical Blood ◽  
Phenylephrine Infusion

Background: Spinal anaesthesia used in caesarian section is associated with hypotension which can have maternal and fetal side effects. To determine the efficacy and ideal dosing of Phenylephrine in attenuating the hypotensive episodes during caesarean section under spinal anaesthesia.Methods: 100 patients were allocated to four groups, placebo group (PE 0) and 3 fixed phenylephrine infusion regimens, phenylephrine 25 μg/min-1 (PE 25), phenylephrine 50 μg/min-1 (PE 50), and phenylephrine 75 μg/min-1 (PE 75). Blood pressure, heart rate were noted among primary variables and fetal parameters like umbilical blood pH and lactate were recorded as secondary parameters.Results: There was a significant reduction in heart rate with increasing the infusion dosage of phenylephrine, with a mean of 86.8 beats/min at the end of procedure in placebo group and 69.4 beats/min in 75 μg group (p value <0.001). There was significant statistical difference among systolic blood pressure in the four groups after 7 min of the procedure and p-value of <0.05 with better attenuation of hypotension in infusion groups as compared to placebo. Similarly there was significant statistical difference in diastolic blood pressure among the four groups after 8 min of the procedure with p values <0.05.Conclusions: Prophylactic phenylephrine infusions reduced the incidence and severity of maternal pre-delivery hypotension. Among the fixed rate phenylephrine infusion regimens investigated, infusion rates of 50 μg/min-1 were associated with greater maternal hemodynamic stability compared with 25 and 75 μg/min-1, with minimal side effects and intervention.

A Phase II Clinical Trial of the Anti-EGFR Antibody Cetuximab in Patients with Refractory or Relapsed Multiple Myeloma: Final Results,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3965-3965
Author(s):  
Bastian von Tresckow ◽  
Boris Böll ◽  
Dennis A. Eichenauer ◽  
Denissa Peine ◽  
Stefan Knop ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Side Effects ◽  
Partial Response ◽  
Stable Disease ◽  
Clinical Benefit ◽  
Single Agent ◽  
Acneiform Rash ◽  
Grade 3 ◽  
Egfr Antibody

Abstract Abstract 3965 INTRODUCTION: So far, monoclonal antibodies have not yielded convincing therapeutic success in multiple myeloma (MM). Therefore, the discovery of an effective targeted antibody against MM would open new perspectives for patients with relapsed or refractory MM and for the combination with established therapies. Cetuximab is an anti-epidermal growth factor receptor (EGFR) antibody. EGFR is also expressed on multiple myeloma (MM) plasma cells and bone marrow stromal cells. Recently, the inhibition of EGFR by small molecule inhibitors has been shown to induce apoptosis in primary myeloma cells revealing a synergistic effect with dexamethasone. Therefore, the anti-EGFR antibody cetuximab might be of clinical benefit in the treatment of MM, especially in combination with dexamethasone. Here we show the final results of the first clinical trial with an anti-EGFR antibody in MM. METHODS: Cetuximab was administered once weekly in standard dose to patients with refractory or relapsed MM who had previously received at least one line of prior treatment including autologous stem cell transplant (ASCT). Patients who still were candidates for ASCT were not included. Dexamethasone 20 mg on day 1–3 of each cycle was added starting week 5 in case of tumor progression or week 9 if no partial response (PR) or complete response (CR) was achieved with cetuximab alone. Planned treatment duration was 16 weeks (primary endpoint) with the possibility to prolong treatment in case of stable disease (SD) or response. RESULTS: In total, 15 patients have been enrolled. Seven patients were treated for a minimum of 16 weeks and 5 of those patients received cetuximab for at least 28 weeks. One patient received cetuximab treatment as single agent for more than one year. Thrombocytopenia, hyponatremia and acneiform rash were the most common CTC grade 3 or 4 side effects. Acneiform rash CTC grade 1 occurred in all patients and 3 patients suffered from acneiform rash CTC grade 3. After 16 weeks (primary endpoint) cetuximab in combination with dexamethasone induced 4 responses (3 minimal responses (MR) and 1 partial response (PR)) and achieved stable disease (SD) in 1 patient. Cetuximab as single agent induced SD in 2 patients. This results in an intention-to-treat overall response rate (ORR; CR+PR+MR) of 27% and a clinical benefit rate (at least SD) of 47%. Five of the 15 patients included did not receive the planned 16 weeks of treatment due to progressive disease (PD); three patients stopped treatment due to intolerable side effects. Six patients were treated more than 16 weeks: 1 patient received cetuximab as single agent and had SD more than a year and 5 patients continued treatment with cetuximab and dexamethasone in combination. CONCLUSIONS: Cetuximab is feasible and safe in MM patients. It demonstrated moderate efficacy in highly pre-treated patients, especially in combination with dexamethasone. Due to its unique mode of action and favorable side effect profile, cetuximab should be evaluated as combination partner for established substances such as bortezomib or lenalidomide to increase response rates both in therapy naive and in refractory patients. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Comparison of prophylactic dexmedetomidine and ketamine for the control of shivering under spinal anaesthesia

2021 ◽  
Vol 8 (5) ◽  
pp. 685
Author(s):  
Rituparna Murmu ◽  
Amartya Das ◽  
Swarupa Roychoudhury
Keyword(s):  
Side Effects ◽  
Spinal Anaesthesia ◽  
Hemodynamic Parameters ◽  
Neuraxial Block ◽  
The Difference ◽  
Prophylactic Use ◽  
Grade 3 ◽  
To Receive ◽  
Group D ◽  
Single Blind

Background: Shivering is a common problem during neuraxial block. Thermoregulatory control gets compromised by neyraxial block and as a result the incidence of shivering can go up to 56.7%. Aim of the current investigation was to evaluate the effectiveness of prophylactic use of intravenous dexmedetomidine and ketamine for the control of shivering and to note any side-effects of the drugs used during subarachnoid block.Methods: This randomised single blind study was conducted in 151 ASA grade I and II patients. SAB was performed with 3.0mL (15 mg) of 0.5% bupivacaine heavy in all patients. Patients were randomly allocated into two groups of 75 and 76each to receive dexmedetomidine (0.5 µg/kg) in group D and ketamine (0.5 mg/kg) in group K respectively. Temperature and hemodynamic parameters were recorded at every 15mins interval. Shivering was graded from 0 to 4 according to Tsai and Chu and if grade 3 shivering occurred, the study was stopped and pethidine 25 mg was given intravenously as rescue drug.Results: 2.67% of patients in group D had shivering whereas 38.16% patients in group K experienced shivering at the 5th minute after spinal anaesthesia and it was statistically significant. However the difference in the incidence of shivering was not statistically significant between the two groups after the initial 5 minutes till the end of surgery.Conclusions: The prophylactic use of dexmedetomidine reduced incidences of shivering more effectively as compared to prophylactic use of ketamine. None of the drugs caused any untoward side effects.

scholarly journals Intravenous Propofol and Inhalational Sevoflurane for Ease of Classic Laryngeal Mask Airway Insertion in Patients Undergoing Elective Surgery: A Randomised Clinical Trial

2021 ◽  
Author(s):  
Nilanjan Chakraborty ◽  
Prosenjit Mukherjee ◽  
Rita Pal
Keyword(s):  
Clinical Trial ◽  
Laryngeal Mask Airway ◽  
Induction Time ◽  
Elective Surgery ◽  
Randomised Clinical Trial ◽  
Laryngeal Mask ◽  
Insertion Time ◽  
P Value ◽  
Induction Agent ◽  
Haemodynamic Changes

Introduction: The Laryngeal Mask Airway (LMA) has gained extensive popularity for airway management during surgery. Propofol, the most commonly used induction agent for LMA insertion, causes significant haemodynamic changes. Sevoflurane has the potential to be as good an induction agent as propofol. Aim: To compare ease of insertion of classic LMA in patients undergoing elective surgery using intravenous propofol and inhalational sevoflurane. Materials and Methods: The study was a randomised clinical trial conducted in the Operation Theatres of Midnapur Medical College and Hospital, Medinipur, West Bengal, India, from August 2019 to July 2020. Eighty patients of American Society of Anaesthesiologists (ASA) physical status grade I and II, of both sexes, and aged between 18 years to 65 years were equally divided into two groups: group P (Propofol group) and group S (Sevoflurane group). Group P was given injection Propofol 2.5 mg/kg body weight and group S was given vital capacity breath induction with 8% sevoflurane and oxygen at 8 litres/min. Loss of Consciousness (LOC) was confirmed and induction time was noted for each group. After confirmation of ease of mouth opening, by an independent observer, LMA insertion was attempted. Ease of LMA insertion was assessed by a predefined 18 points table along with time to LMA insertion and number of attempts. Haemodynamic changes and adverse effects were also recorded. Chi-square test or Student’s t-test were used and a p-value ≤0.05 was considered as statistically significant. Results: With respect to age, sex and weight there were no significant differences between the two groups. Induction time was significantly less in group P (51.85±6.66 seconds) compared to group S (68.38±13.93 seconds) (p-value=0.0001), but LMA insertion time, number of attempts and overall ease of LMA insertion conditions according to the 18 points score were comparable between the two groups. Mean arterial pressure at certain points after induction was significantly less in group P (at 3 minute p-value=0.009 and at 5 minute p-value=0.007). Apnea was significantly more in group P (p-value=0.023). Conclusion: Sevoflurane was comparable to propofol for LMA insertion in respect of ease of insertion and insertion time. Although induction time was significantly less for propofol, sevoflurane offered better haemodynamic stability and lesser incidence of apnea.

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