Anesthesia and analgesia
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Anesthesia and analgesia · Oct 1999
Randomized Controlled Trial Comparative Study Clinical TrialComparison of the sedation and recovery profiles of Ro 48-6791, a new benzodiazepine, and midazolam in combination with meperidine for outpatient endoscopic procedures.
In this randomized, double-blinded study, we compared the onset and recovery characteristics of an investigational benzodiazepine, Ro 48-6791 (when administered alone or combined with meperidine), a midazolam-meperidine combination for sedation during gastrointestinal (GI) endoscopic procedures. Ninety consenting outpatients scheduled for upper or lower GI procedures were randomly assigned as follows: Group I received midazolam 1 mg IV and meperidine 50 mg; Group II received Ro 48-6791 0.5 mg IV and meperidine 50 mg; or Group III received Ro 48-6791 1.0 mg IV alone. If the level of sedation did not achieve an Observer's Assessment of Alertness/Sedation (OAA/S) score of 4 (where 5 = awake/alert to 1 = asleep) in < or = 2 min, a second bolus dose, equal to half of the original dose of midazolam or Ro 48-6791, was administered. The onset time was defined as the time to achieve an OAA/S score of 4. During the procedure, a bolus dose equal to half of the total induction dose was given to maintain an OAA/S score of 4. The induction and maintenance dosages, as well as recovery times to an OAA/S score of 5, were recorded. A heel-toe line walk (HTLW) test used to determine the time to "fitness for discharge." Although the onset times were similar in all three groups, the induction dosages were significantly reduced in Group II compared with Groups I and III. There were significantly more patients requiring supplemental sedative boluses and "rescue" analgesia with Ro 48-6791 than with midazolam. The Ro 48-6791 groups also experienced more dizziness after the procedures. Ro 48-6791 was associated with a higher incidence of inadequate sedation (18% vs 3%) without the opioid. The time for the HTLW test to return to baseline values after the procedure was similar among the three groups. However, the Ro 48-6791 groups had significantly reduced times to return to an OAA/S score of 5 and to achieve the baseline HTLW value after the last dose of the benzodiazepine. In conclusion, compared with midazolam, Ro 48-6791 is more potent and may be associated with a more rapid early recovery after endoscopic GI procedures. However, sedation with Ro 48-6791 required more supplemental bolus doses and "rescue" analgesic medication and was associated with a higher incidence of dizziness. ⋯ The investigational water-soluble benzodiazepine, Ro 48-6791, is a more potent sedative than midazolam, which appears to have a slightly shorter duration of action. Unfortunately, use of Ro 48-6791 increased the requirement for supplemental doses of the sedative medication and the need for "rescue" analgesics during the procedure and was associated with more dizziness after the procedure.
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Anesthesia and analgesia · Oct 1999
Randomized Controlled Trial Clinical TrialMulti-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study.
Pain is the dominant complaint after laparoscopic cholecystectomy. No study has examined the combined effects of a somato-visceral blockade during laparoscopic cholecystectomy. Therefore, we investigated the effects of a somato-visceral local anesthetic blockade on pain and nausea in patients undergoing elective laparoscopic cholecystectomy. In addition, all patients received multi-modal prophylactic analgesic treatment. Fifty-eight patients were randomized to receive a total of 286 mg (66 mL) ropivacaine or 66 mL saline via periportal and intraperitoneal infiltration. During the first 3 postoperative h, the use of morphine and antiemetics was registered, and pain and nausea were rated hourly. Daily pain intensity, pain localization, and supplemental analgesic consumption were registered the first postoperative week. Ropivacaine reduced overall pain the first two hours and incisional pain for the first three postoperative hours (P < 0.01) but had no apparent effects on intraabdominal or shoulder pain. During the first 3 postoperative h, morphine requirements were lower (P < 0.05), and nausea was reduced in the ropivacaine group (P < 0.05). Throughout the first postoperative week, incisional pain dominated over other pain localizations in both groups (P < 0.01). We conclude that the somato-visceral local anesthetic blockade reduced overall pain during the first 2 postoperative h, and nausea, morphine requirements, and incisional pain were reduced during the first 3 postoperative h in patients receiving prophylactic multi-modal analgesic treatment. ⋯ A combination of incisional and intraabdominal local anesthetic treatment reduced incisional pain but had no effect on deep intraabdominal pain or shoulder pain in patients receiving multimodal prophylactic analgesia after laparoscopic cholecystectomy. Incisional pain dominated during the first postoperative week. Incisional infiltration of local anesthetics is recommended in patients undergoing laparoscopic cholecystectomy.