Introduction:Colonoscopy is a mildly painful procedure requiring conscious sedation. Though propofol is a widely used anesthetic agent in day-care procedures due to its rapid onset and quick recovery has a drawback of requiring resuscitation maneuvers more often than the conventional methods. Dexmedetomidine, a newly introduced, highly selective α2-adrenergic receptor agonist possessing hypnotic, sedative, anxiolytic, sympatholytic, and analgesic properties with impressive safety margin, needs to be explored for use in conscious sedation for colonoscopy procedure among South Indian population.Materials and Methods:A prospective randomized comparative study was conducted on patients aged between 25 and 60 years with the American Society of Anesthesiologist physical status classes I and II posted for colonoscopy under monitored anesthesia care. Study group was randomly divided into two groups and administered propofol and dexmedetomidine. The primary outcome variable was assessments of sedation scores between the two groups. Secondary outcome variables were pain score assessments, hemodynamic comparisons, and adverse events among the two groups. Appropriate statistical tests were applied to compare the findings.Results:After comparisons between the two groups, we found that patients on dexmedetomidine had similar sedation score as that of patients on propofol. However, there was a significantly higher incidence of systemic hypotension. Requirement of rescue analgesia and adverse events and other hemodynamic fluctuation were similar in both the groups.Conclusion:We conclude that dexmedetomidine has similar efficacy as propofol for conscious sedation required during colonoscopy. Occurrence of systolic hypotension was, however, significantly more among the group receiving dexmedetomidine.

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6041 Background: Patients (pt) with advanced inoperable squamous cell carcinoma of the head and neck (SCCHN) have poor radiotherapy alone (RT) outcome. EGFR is over-expressed in >90% SCCHN. h-R3mAb (BIOMAb/nimotuzumab/TheraCIM) is a humanized monoclonal antibody, a validated oncotherapeutic-targeting EGFR. Objective: To investigate the safety and efficacy of concurrent h-R3mAb in combination with chemoradiotherapy of SCCHN. Methods: September 2004–2005, pt 18–70 yrs, SCCHN stageIII-IVA, 113 screened, 92 enrolled and randomly asssigned to, Group A: radical radiotherapy (pt) and Group B: chemoradiotherapy (pt). Randomization within Group A: [RT]v/s[RT+h-R3mAb] and within Group B: [RT+CT]v/s[RT+CT+ h-R3mAb] (n = 23 in each arm). Protocol: Radiotherapy: TD: 66 Gy,2Gy/Fr,5Fr/w,6.5wks. Radiation sensitizer (chemotherapy): CDDP-50mg/wk x 6wks. Study Drug (h-R3mAb): 200 mg/wk I.V.60min x 6weeks. Results: Evaluable (n = 76) in Group A-36 and Group B-40. F/u Analysis at 30 months after end of RT. Survival rate ITT: Group B: CT+RT+hR3- 69.5% v/s CT+RT-21.7% (p - 0.0011), Group A: RT alone - 21.7% v/s RT+ hR3–39.1% (ns). Progression-free survival: RT alone - 3(13.04 %) v/s RT+hR3mAb-8 (34.78 %), RT+CT-5 (21.74 %) v/s RT+CT+hR3mAb-13 (56.52%). Median overall survival (OS): CT+RT+hR3 - NR* v/s CT+RT- 21.96 months (hazard ratio [HR]-0.337, p - 0.0018) and RT alone - 25.02 v/s RT+hR3 - NR*(HR-0.678, p - 0.39). Disease-free survival: CT+RT+hR3- NR*v/sCT+RT-21.30 mths (HR-0.344, p - 0.0052) and RT alone-25.02 v/s RT+hR3- NA* (HR-0.599, p - 0.32). (NR*- median OS is yet to be reached). Safety: few grade - 1/2AE, no HAMA observed. OS per protocol - adding h-R3mAb to chemoradiation resulted in a reduction in risk of death (rrd) by 85% (HR 0.15, p - 0.0006) and to RT a 36 % rrd (HR0.64, p - 0.33). Conclusions: Concurrent use of h-R3mAb with RT or RT+CT is safe and efficacious. It enhances radiation and chemotherapy responses. Concurrent use of h-R3mAb with chemoradiotherapy enhances long-term loco-regional control and survival. Adding biological agents to physically targeted modality improves long-term therapeutic outcome of SCCHN. No significant financial relationships to disclose.

Background and Aims: Evaluations of adverse heart rate (HR)-responses and HR-variations during anaesthesia in beach-chair-position (BCP) for shoulder surgeries have not been done earlier. We analysed the incidence, associations, and interpretations of adverse HR-responses in this clinical setting. Methods: We performed a meta-analysis of trials that reported HR-related data in anaesthetised subjects undergoing elective shoulder surgeries in BCP. Studies included prospective, randomised, quasi-randomised and non-randomised, controlled clinical trials as well as observational cohorts. Literature search was conducted in MEDLINE, EMBASE, CINHAL and the Cochrane Central Register of Controlled Trials of the 21 st century. In the first analysis, we studied the incidence and associations of bradycardia/hypotension-bradycardia episodes (HBE) with respect to the type of anaesthesia and different pharmacological agents. In the second, we evaluated anaesthetic influences, associations and inter-relationships between monitored parameters with respect to HR-behaviours. Results: Among the trials designed with bradycardia/HBE as a primary end point, the observed incidence of bradycardia was 9.1% and that of HBE, 14.9% and 22.7% [(for Interscalene block (ISB) ± sedation) subjects and general anaesthesia (GA) + ISB, respectively]. There was evidence of higher observed risk of developing adverse HR-responses for GA subjects over ISB (Risk Difference, P < 0.05). Concomitant use of β-agonists did not increase risk of HBEs ( P = 0.29, I 2 = 11.4%) or with fentanyl ( P = 0.45, I 2 = 0%) for ISB subjects (subgroup analysis). Fentanyl significantly influenced the HR-drop over time [meta-regression, estimates (standard error), 14.9 (5.4), 9.8 (4.3) and 17 (2.6); P = 0.007, 0.024 and <0.001; for early, mid and delayed periods, respectively] in GA subjects. With respect to number of subjects experiencing cerebral desaturation events (CDEs), total intravenous anaesthesia (TIVA)- propofol had higher risk over inhalational anaesthesia ( P = 0.006, I 2 = 86.7%). Meta-correlation analysis showed relationships between the HR and rSO 2 (regional cerebral oxygen saturation) or SjvO 2 (jugular venous oxygen saturation) values (r = 0.608, 95%CI, 0.439 to 0.735, P < 0.001, I 2 = 77.4% and r = 0.397, 95%CI, 0.151 to 0.597, P < 0.001, I 2 = 64.3%, respectively). Conclusions: There is not enough evidence to claim the associations of adverse HR-responses with any specific factor. H...

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